Abstract
A workshop on “Clinical Translation of Molecular Imaging Probes and Technology” was held August 2, 2013 in Bethesda, Maryland, organized and supported by the National Institute of Biomedical Imaging and Bioengineering (NIBIB). This workshop brought together researchers, clinicians, representatives from pharmaceutical companies, molecular probe developers, and regulatory science experts. Attendees met to talk over current challenges in the discovery, validation, and translation of molecular imaging (MI) probes for key clinical applications. Participants also discussed potential strategies to address these challenges. The workshop consisted of 4 sessions, with 14 presentations and 2 panel discussions. Topics of discussion included (1) challenges and opportunities for clinical research and patient care, (2) advances in molecular probe design, (3) current approaches used by industry and pharmaceutical companies, and (4) clinical translation of MI probes. In the presentations and discussions, there were general agreement that while the barriers for validation and translation of MI probes remain high, there are pressing clinical needs and development opportunities for targets in cardiovascular, cancer, endocrine, neurological, and inflammatory diseases. The strengths of different imaging modalities, and the synergy of multimodality imaging, were highlighted. Participants also underscored the continuing need for close interactions and collaborations between academic and industrial partners, and federal agencies in the imaging probe development process.
Highlights
Molecular imaging plays an important role in advancing knowledge about disease pathophysiology, and diagnostic tools have been developed based on molecular imaging probes and technology
While accumulation of white adipose tissue is associated with obesity, it has been shown that lean men have more brown adipose tissue (BAT) than obese men [21], and the metabolic activities of BAT can be protective against diet-induced obesity [22]
A representative from Center for Medicare and Medicaid Services (CMS) raised a number of important points concerning Medicare coverage of diagnostic tests, as they apply to molecular imaging probes: (1) diagnostic tests are rarely therapeutic; (2) diagnostic testing may expose a patient to specific short- or long-term risks; (3) while potential harm may occur, diagnostic tests accrue benefits and can inform downstream clinical management of the patients (4) balance of risk and harm should consider the acuity and severity of the patient’s presentation; (5)
Summary
NIH Workshop on Clinical Translation of Molecular Imaging Probes and Technology—Meeting Report.
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