Institutional Radiation Safety Research Articles

Optimizing Regulatory Reviews for Clinical Protocols that Use Radiopharmaceuticals: Findings of the University of Pennsylvania Radiation Research Safety Committee.

Institutional radiation safety committees review research studies with radiation exposure. However, ensuring that the potential patient benefit and knowledge gained merit the radiation risks involved often necessitates revisions that inadvertently delay protocol activations. This quality-improvement study analyzed protocols, identified factors associated with approval time by a radiation safety committee, and developed guidelines to expedite reviews without compromising quality. Clinical protocols submitted to the University of Pennsylvania's Radiation Research Safety Committee (RRSC) for review between 2017 and 2021 were studied. Protocol characteristics, review outcome, stipulations, and approval times were summarized. Statistical analysis (Spearman's rho) was used to investigate stipulations and approval time; rank-sum analysis (Kruskal-Wallis or Wilcoxon) was used to determine whether approval time differed by protocol characteristics. One hundred ten (110) protocols were analyzed. Approximately two-thirds of protocols used approved radiopharmaceuticals to aid investigational therapy trials. Twenty-three percent (23%) of protocols received RRSC approval, and 73% had approval withheld with stipulations, which included requests for edits or additional information. Submissions had a median of three stipulations. Median and mean RRSC approval times were 62 and 80.1 d, and 41% of protocols received RRSC approval after IRB approval. RRSC approval time was positively correlated with stipulations (Spearman's rho = 0. 632, p < 0.001). RRSC approval time was longer for studies using investigational new drugs (median 80 d) than approved radiopharmaceuticals (median 57 d, p = 0.05). The review process is lengthy and may benefit from changes, including publishing standardized radiation safety language and commonly required documents and encouraging timely response to stipulations.

Novel EUS-guided brachytherapy treatment of pancreatic cancer with phosphorus-32 microparticles: first United States experience.

Pancreatic adenocarcinoma is one of the most lethal and therapeutically resistant malignancies.1National Cancer InstituteSurveillance, Epidemiology, and End Results Program. Cancer Stat Facts: Pancreatic Cancer. Volume 2018, 2018.https://seer.cancer.gov/statfacts/html/pancreas.htmlGoogle Scholar There is no uniform consensus regarding standard of care for treatment of unresectable, locally advanced pancreatic cancer (LAPC). Treatment options include chemotherapy alone, chemotherapy followed by chemoradiotherapy, or stereotactic body radiation therapy.2Cardenes H.R. Chiorean E.G. DeWitt J. et al.Locally advanced pancreatic cancer: current therapeutic approach.Oncologist. 2006; 11: 612-623Crossref PubMed Scopus (79) Google Scholar, 3Herman J.M. Chang D.T. Goodman K.A. et al.Phase 2 multi-institutional trial evaluating gemcitabine and stereotactic body radiotherapy for patients with locally advanced unresectable pancreatic adenocarcinoma.Cancer. 2015; 121: 1128-1137Crossref PubMed Scopus (338) Google Scholar We describe here our first experience with an EUS-guided implantation of a novel brachytherapy device, phosphorus-32 microparticles (P-32 OncoSil, in conjunction with standard chemotherapy in a patient with LAPC) (Video 1, available online at www.VideoGIE.org). The P-32 was administered as part of the OncoPaC-1 clinical trial (ClinicalTrials.gov number, NCT03076216) approved by the institutional review board at our institution. P-32 is an experimental medical device intended for use in brachytherapy that carries the radioactive β-emitter P-32 inside inactive silicon particles. It is implanted into pancreatic tumors by EUS during the 4th or 5th week of the first cycle of chemotherapy (Fig. 1). A 72-year-old man presented with epigastric pain radiating to the midback. CT of the abdomen showed a 5.0- × 3.6-cm hypodense mass in the pancreatic body, encasing the splenic vein, splenic artery, celiac axis, and portal vein confluence (Fig. 2). Enlarged intra-abdominal lymph nodes were also identified. Cytologic examination of an EUS-guided FNA specimen revealed adenocarcinoma. The CA 19-9 marker was markedly increased: 635 U/mL (normal, 0-35 U/mL). The patient was informed about the OncoPaC-1 clinical trial, and he opted to be treated on protocol. The patient started chemotherapy with gemcitabine + nab-paclitaxel. The predefined suspension preparation protocol of P-32 microparticles stated that the final radioactive concentration of P-32 required to deliver 100 Gy to the tumor should be 6.6 MBq/mL. As per protocol, the microparticles should be suspended in 8% of the tumor volume. In this case, the tumor volume was 23.3 mL, and the calculated dose of P-32 microparticles was determined to be 1.87 mL, corresponding to a radioactivity dose of 12.3 MBq. EUS was performed to deliver the P-32 into the pancreatic tumor during the 4th week of the first chemotherapy cycle. A 22-gauge needle was used to puncture the tumor by use of a transgastric approach through an avascular angle. The P-32 was injected into the center of the tumor with a needle tracking technique by pulling the needle back when the injection became difficult. One mL of saline solution was used to flush the P-32 remaining in the needle into the tumor, and then the needle was withdrawn back into the sheath. The injection of P-32 was seen as an echogenic blush within the tumor (Fig. 3). Radiation safety is an important consideration in the use of P-32. After the procedure, all materials were sterilized and disposed of according to radiation safety guidelines and under the supervision of the institutional radiation safety department. Whole-body planar and single photon emission computed tomography (SPECT)/CT scintigraphic imaging of P-32 bremsstrahlung radiation was performed within 4 hours after implantation and again at 7 days to assess the intratumoral and any potential extratumoral distribution of the P-32 microparticles. Both SPECT/CT scans confirmed local collection of the radioactivity in the known pancreatic tumor (Fig. 4). The chemotherapy regimen was resumed after implantation. Follow-up CT scans were repeated every 8 weeks to assess tumor response. CT scan assessments showed a 58% decrease in tumor volume from baseline (23.2 mL) to week 16 (9.7 mL) (Fig. 5). There was improvement of the caliber of the splenoportal confluence, which would also be indicative of tumor response. The patient had the follow-up visit at week 22. His pre-existing abdominal pain completely resolved, and the serum CA 19-9 level (25 U/mL) has trended downward significantly. The patient is currently without side effects or toxicity from the implant procedure, and he has been able to successfully continue his chemotherapy regimen. Our first experience with P-32 brachytherapy in conjunction with chemotherapy in a patient with LAPC showed that this novel treatment modality is promising and technically feasible. Given the 58% decrease in tumor volume, we believe the response is beyond what would be expected from chemotherapy alone. The final results of this trial are expected to shed further light on the safety and efficacy of P-32 brachytherapy.

Level of Practical Skills in Personnel Dosimetry Monitoring and the Laboratory Experience with Different Types of TLD Readers

This study was carried out to analyze individual annual dose records of diagnostic radiology staff at forty-eight (48) different medical facilities in urban and rural Region of Ghana for the period of 2011-2015. The monitored dose data were extracted from the Radiation Protection Institute of the Ghana Atomic Energy Commission’s database called the Dose Management System (DMS). The doses of these OEWs analyzed, are divided into four subgroups namely; general radiographers, radiologists, computed tomography (CT) technologists, fluoroscopy technologists. The dose distribution, collective dose and mean annual dose were determined. A total of 1574 OEWs were monitored comprising of 56% radiographers, 15% radiologist, 21% computed tomography (CT) technologists and 8% fluoroscopy technologists. The average annual effective dose ranged from 0.36 to 1.70 mSv with radiographers receiving the largest. Fluoroscopy technologist recorded the least annual total collective effective dose value of 0.1 person-Sv. The study contributes to the existing works to promote a more comprehensive personal monitoring service for OEWs. Continued analysis of occupational doses should be an integral component of institutional radiation safety programs in Ghana.

A retrospective study for occupational effective doses amongst and within employees of a Nuclear Medicine Department

Routine monitoring of occupational radiation exposure is done primarily to demonstrate compliance with dose limits. Analysis of past and present dose records provides a useful tool in the management of institutional radiation safety programs. In this study, an analysis of annual dose records from 1995 to 2015 is performed with the data from a nuclear medicine department where both radionuclide treatment and diagnostic imaging are done at a large scale. All radiation employees in the department were educated on their own subjects and experienced in their duties. They have been receiving periodic trainings about radiation protection. In this way, the annual effective dose values are limited to the minimum. Large variation in the mean annual dose exists among the different occupational groups. Among the workers, technologists received the largest annual effective dose. The study evaluates differences in occupational exposure within this group of workers performing the same procedure, and the efficacy of safety protocols. Continuing education and optimization of working technics can help minimize the radiation exposure of the workers. Limits can be assured to remain well below the acceptable values by incorporating the mechanism of job rotations.

Development of a policy to improve oversight of extremely hazardous chemicals

At the University of Nevada, Reno (UNR) the use of radioactive materials and biological agents in laboratory research requires approval by the institutional radiation safety committee and biosafety committee, respectively. Investigators who want to use hazardous chemicals, however, do not have to obtain approval. This disparity in institutional oversight of different classes of hazardous materials is a result of more stringent regulatory and research funding requirements rather than the hazards posed by the materials themselves. Recognizing the potential for severe incidents involving highly reactive chemicals and other extremely hazardous chemicals, development of a policy for review of these chemicals was initiated. Development of this policy involved establishing the scope and inclusion criteria, consideration of the effect on laboratory research productivity, diplomacy, and compromise. Development of this policy in its current draft format is described.

WE-E-137-01: RSO Refresher Training

The Role of the Radiation Safety Officer in the Medical InstitutionMedical institutions generally have a variety of sources of ionizing radiation including radioactive materials, x-ray devices, and linear accelerators. The role of the RSO can vary widely from one facility to the next. The authority for the regulatory oversight of radioactive materials is delegated to the RSO via a radioactive materials license, and the responsibilities are clearly established. However, authority over other sources of ionizing radiation is less clear which can Result in significant gaps in radiation safety management programs. The responsibility of the RSO is least clear in the area of Radiation Therapy. The RSO may be involved in oversight where radioactive materials are used, but rarely are involved in oversight of external beam therapy. The lack of clarity regarding oversight authority, roles and responsibilities has led to medical events and serious gaps in radiation safety that leave patients, workers and the public at risk. Each institution must perform a thorough review to ensure that a consistent framework for managing radiation safety for all sources of ionizing radiation is applied. The Role of the Radiation Safety Officer in Nuclear MedicineNuclear medicine needs be practiced in a manner that is effective, safe for both employees and patients and compliant with all local, state and federal regulations. It is also imperative to meet the standards set by accrediting bodies such as the Joint Commission. Therefore, it is essential that the radiation safety officer work closely with the professional and technical staff working in nuclear medicine to accomplish this. In this presentation, the role of the radiation safety officer in nuclear medicine and the partnership between radiation safety and nuclear medicine will be discussed. This discussion will be in the context of both smaller programs with a specific radioactive materials license as well as larger programs with a broad license where institutional radiation safety committee may also be established. The items that will be review will be establishment of a hot laboratory for handling radiopharmaceuticals, the planning of an imaging room, particularly in the context of hybrid imaging, the acceptance of radiopharmaceutical shipments, personnel monitoring and the implementation of a set of good practices for radiation safety. Lastly, the communication of radiation dose and its potential, associated risk with patients and their families will be discussed. Learning Objectives: 1. To understand the role and responsibilities of the Radiation Safety Officer within a medical institution 2. To understand the role and responsibilities of the Radiation Safety Officer in a Nuclear Medicine Department. 3. To be aware of health physics responsibilities that often are part of the responsibilities of the medical physicist. 4. To understand the responsibility for safety with all sources of radiation, machines and materials.

Informed Consent in Human Research

To ensure that the possibility of harm to human research subjects is minimized, clinical trials and other research protocols are subject to oversight by Institutional Review Boards (IRBs). IRBs require that subjects be fully informed about the real or potential risks of participation in a research study. The use of radiological examinations in research protocols subjects the participants to exposure to ionizing radiation, which in theory carries a risk of stochastic effects such as radiation-induced cancer, and in practice may lead to deterministic effects such as skin injury. Because IRB members and clinical study coordinators may have little knowledge of radiation effects or how best to communicate the risk to the research subjects, they will consult with institutional Radiation Safety Committees and radiation protection professionals regarding how to integrate radiation risk information into the informed consent process. Elements of radiation informed consent include: (1) comparison of the radiation dose to some benchmark that enables the study subjects to make a value judgment regarding the acceptability of the risk; (2) a quantitative expression of the absolute risk of stochastic effects; (3) an expression of uncertainty in the risk; and (4) understandability. Standardized risk statement templates may be created for specific radiological examinations. These standardized risk statements may be deployed as paper forms or electronically in the form of internet-based applications. The technical nature of creating useful radiation risk statements represents an opportunity for radiation protection professionals to participate productively in the clinical research process.

SU‐FF‐I‐44: Management of Patient Radiation Dose in Interventional Fluoroscopy

Purpose: Some complex interventional procedures require significant amounts of radiation for their completion. In 2006 JCAHO added a 15Gy single field fluoroscopic skin dose to the list of sentinel events. An active radiation management program contributes to optimization of the patient's benefit/risk ratio. Method and Materials: Periodic equipment quality testing and calibration. Patient radiation history to determine the quantity and location of previous significant radiation events Appropriate patient consent Operator and staff dose management during the procedure Documentation and clinical follow‐up when significant doses of radiation are used Continuing clinical follow‐up when deterministic injuries are suspected or observed Results: Our program was implemented in June 2005. Significant issues include acquisition of the patient's radiation history, active management of dose rate by operators during procedures, and complete documentation at the end of each procedure. Post procedural patient discussions and integrating radiation follow‐up into our standard 30 day post‐intervention telephone call were easy. The initial trigger level for immediate justification of significant radiation usage and patent follow up was 3 Gy cumulative dose at the IEC interventional reference point. In January 2006 and after consultation with the institutional radiation safety committee, the trigger was raised to 5 Gy (corresponding to a peak skin dose in the range 2 –3 Gy for most procedures). Special rules apply to patients with unusual or multiple procedures. Conclusion: The world‐wide occurrence of a major deterministic injury is estimated to be one or two orders of magnitude less frequent than death from an interventional procedure. Simple technical improvements such as better dose displays, low‐dose‐rate defaults, and automated data collection would be helpful. With these, operators and monitoring nurses can more easily maintain a level of dose awareness during a procedure appropriate to an ongoing benefit/risk analysis.

A Fluoroscopic Credentialing/Safety Program at a Large Research Hospital

The Brigham and Women's Hospital is an ~700 bed broad-scope licensed facility with a vigorous fluoroscopy service. Concomitant with this service is an equally robust quality management program to safeguard both patient and personnel from excessive radiation doses. The FDA, in an attempt to avoid serious skin injury for certain fluoroscopically guided procedures, issued a Public Health Advisory in 1994. Four years later the institutional Radiation Safety Committee voted to expand an existing fluoroscopic safety course to include a more formal credentialing/safety requirement. The specific parameters associated with this program follow.

Estimation of a radiation time prolongation factor for intensity-modulated radiotherapy

In general, the deposition of a given target dose requires a longer radiation time for intensity-modulated photon beams (IMBs) than for unmodulated beams. Hence, the routine use of intensity-modulated radiotherapy (IMRT) has repercussions both on the exposure of the patient to scatter and institutional radiation safety. A rule of thumb is presented to assess the maximum prolongation of radiation time for a case class in an idealized setting using static superimposed field segments. The method considers only the degree to which risk structures have to be blocked to meet specified dose restrictions.

Statistical analysis of historical occupational dose records at a large medical center.

Routine monitoring of occupational radiation exposure is done primarily to demonstrate compliance with dose limits. Statistical analysis of past and present dose records provides a useful tool in the management of institutional radiation safety programs. In this study, a statistical analysis of annual dose records from 1985-1999 from a large tertiary care medical center with a cyclotron and radiopharmaceutical production facility is performed. A total of 6,089 annual dose records, categorized into ten occupational groups, were included in the analysis. Dose distribution is skewed, with 85% of workers receiving an annual dose of less than 1.0 mSv, while 1.3% have doses > or =10 mSv. The mean annual dose of all monitored workers during this 15-y period ranged from 0.5 to 1.2 mSv. Large variation in the mean annual dose exists among the different occupational groups. Four occupational groups were identified as relatively highly exposed, namely cyclotron and radiopharmaceutical production, cardiac catheterization, nuclear medicine, and diagnostic radiology. These four occupational groups also showed different trends in the mean annual dose. A correlation study showed that total annual collective dose has no linear association with the number of monitored workers, the number of measurably exposed workers, or the number of workers with annual dose between 0.1 to <10 mSv. Moderate correlation (r = 0.64) was observed between the annual collective dose and the collective dose of workers with an annual dose between 0.1 to <10 mSv. A strong and significant correlation (r = 0.95) exists between the total annual collective dose and both the number of workers with annual dose of > or =10 mSv and the corresponding collective dose due to these highly exposed workers. Although the fraction of these highly exposed workers is small (about 1%), they have a significant impact on the total collective dose and their contribution can be as high as 50%. Workers with annual dose of > or =10 mSv tend to concentrate in a few identified occupational groups and not across all occupational groupings. The cyclotron and radiopharmaceutical production department is of particular concern due to its high individual dose levels and increasing mean annual dose trend for the last 5 y. Radiochemists and cyclotron engineers tend to receive an annual dose exceeding the dose limit. A plot of the collective dose of highly exposed workers vs. the total collective dose shows that if a dose constraint of 10 mSv is imposed on highly exposed occupational groups, the total collective dose is expected to be about 200 person-mSv.

Piloting a new radiation protection program strategy: rewarding compliance rather than sanctioning non-compliance.

In an attempt to improve compliance with historically problematic radiation protection program requirements, a novel incentive program was created in cooperation with a major vendor of biomedical research products. Researchers using radioisotopes that placed orders from a partnering vendor were afforded an added price discount if verified by the institutional radiation safety program to be in compliance with laboratory contamination survey requirements. The program, piloted for a period of 1 y, resulted in a total institutional savings of approximately $2,200 and a 27% improvement in compliance with targeted objectives when compared with previous years. Feedback from pilot participants was extremely positive, as the program served to shift the perception of the radiation protection program from one that sanctions non-compliance to one that rewards compliance. The relative success of the pilot program suggests that the approach may be broadly applicable both within radiation safety programs and other safety-related settings as well.

A proposed method to minimize waste from institutional radiation safety surveillance programs through the application of expected value statistics.

Institutional radiation safety programs routinely use wipe test sampling and liquid scintillation counting analysis to indicate the presence of removable radioactive contamination. Significant volumes of liquid waste can be generated by such surveillance activities, and the subsequent disposal of these materials can sometimes be difficult and costly. In settings where large numbers of negative results are regularly obtained, the limited grouping of samples for analysis based on expected value statistical techniques is possible. To demonstrate the plausibility of the approach, single wipe samples exposed to varying amounts of contamination were analyzed concurrently with nine non-contaminated samples. Although the sample grouping inevitably leads to increased quenching with liquid scintillation counting systems, the effect did not impact the ability to detect removable contamination in amounts well below recommended action levels. Opportunities to further improve this cost effective semi-quantitative screening procedure are described, including improvements in sample collection procedures, enhancing sample-counting media contact through mixing and extending elution periods, increasing sample counting times, and adjusting institutional action levels.

Assessing the service provided by an institutional radiation safety survey program.

Routine radiation safety surveys are a required part of every institutional radiation protection program. Although mandated by regulation, surveys are really performed to help clinicians and researchers establish and maintain radiologically-safe working and learning environments. In some cases, however, the priorities established by a radiation protection program may not coincide with the needs perceived by the institution's workers, leading to possible alienation, dissatisfaction, and non-compliance with policies, procedures, and regulations. To determine if a typical survey program was perceived as providing a good or valued service to workers, a simple questionnaire was created and utilized for a 6-mo period The results obtained from this targeted assessment tool indicate that the radiation safety survey services were perceived as useful by most of the workers. In addition, the actual process of comment solicitation provided a positive feedback mechanism from the service recipients to the radiation safety staff, managers, committee members, and institution administrators.

Simple physical, chemical, and biological safety assessments as part of a routine institutional radiation safety survey program.

To assist in providing comprehensive surveillance for potential health and safety hazards, simple assessments of physical, chemical, and biological safety concerns were incorporated into traditional radiation safety facility surveys for a biomedical research and clinical care facility for a 1-y period. Customized training was provided to radiation safety staff members concerning each of the hazard areas identified and a brief checklist was developed. During the 1-y period 802 laboratory and clinic surveys were performed, and of the 372 safety issues noted by the staff, approximately 55% were identified as not related to traditional health physics surveillance activities. The utilization of these simple safety audit tools as part of a routine radiation safety surveillance program can serve as a cost effective way to assist in maintaining a teaching, research, and clinical environment that is free from a variety of recognized hazards.