Abstract
Strategies to procure high-quality core-needle biopsy (CNB) specimens are critical for making basic tissue diagnoses and for ancillary testing. To investigate acquisition of fluorescence confocal microscopy (FCM) images of interventional radiology (IR)-guided CNB in real time in the radiology suite and to compare the accuracy of FCM diagnoses with those of hematoxylin-eosin (H&E)-stained CNB sections. In this diagnostic study, FCM imaging of IR-guided CNBs was performed in the radiology suite at a major cancer center for patients with an imaging abnormality from August 1, 2016, to April 30, 2019. The time taken to acquire FCM images and the quality of FCM images based on percentage of interpretable tissue with optimal resolution was recorded. The FCM images were read by 2 pathologists and categorized as nondiagnostic, benign/atypical, or suspicious/malignant; these diagnoses were compared with those made using H&E-stained tissue sections. Cases with discrepant diagnosis were reassessed by the pathologists together for a consensus diagnosis. Data were analyzed from June 3 to July 19, 2019. Each IR-guided CNB was stained with 0.6mM acridine orange, subjected to FCM imaging, and then processed to generate H&E-stained sections. Mean time taken for acquisition of FCM images, quality of FCM images based on interpretable percentage of the image, and accuracy of diagnostic categorization based on FCM images compared with H&E-stained sections. A total of 105 patients (57 male [54.3%]; mean [SD] age, 63 [13] years) underwent IR-guided CNBs in a mean (SD) of 7 (2) minutes each. The FCM images showed at least 20% of the tissue with optimal quality in 101 CNB specimens (96.2%). The FCM images were accurately interpreted by the 2 pathologists in 100 of 105 cases (95.2%) (2 false-positive and 3 false-negative) and 90 of 105 cases (85.7%) (6 false-positive and 9 false-negative). A reassessment of 14 discordant diagnoses resulted in consensus diagnoses that were accurate in 101 of 105 cases (96.2%) (1 false-positive and 3 false-negative). The ease of acquisition of FCM images of acceptable quality and the high accuracy of the diagnoses suggest that FCM may be useful for rapid evaluation of IR-guided CNBs. This approach warrants further investigation.
Highlights
Interventional radiology (IR)–guided core-needle biopsy (CNB) is the most commonly used procedure for procuring tissue for the investigation of radiologically identified abnormalities in solid organs
The ease of acquisition of fluorescence confocal microscopy (FCM) images of acceptable quality and the high accuracy of the diagnoses suggest that FCM may be useful for rapid evaluation of IR-guided CNBs
We found no discrepancy in the categorization of the H&E-stained sections between pathologist 1 and the histologic diagnosis in the final pathology report
Summary
Interventional radiology (IR)–guided core-needle biopsy (CNB) is the most commonly used procedure for procuring tissue for the investigation of radiologically identified abnormalities in solid organs. Our ability to realize the potential of personalized medicine depends on the availability of CNB specimens with optimal tumor cellularity together with preserved tissue integrity.[1] The lack of high-quality tissue specimens is a critical roadblock to developing and validating cancer biomarkers.[2] A large number of clinical trials fail to perform pharmacodynamic analyses or report incomplete findings from such analyses owing to suboptimal tissue biopsies.[3,4] At present, as many as 15% of CNB specimens procured from solid tumors demonstrate insufficient tissue for ancillary molecular testing using any of the currently available genomic platforms.[5] There is ongoing discussion to improve the acquisition of high-quality CNB specimens for patient care and for successful completion of ancillary testing in clinical trials.[6,7,8] A minimum tumor cellularity of 20% is generally required for ancillary genomic testing using next-generation sequencing.[9] Strategies to ensure high-quality CNBs are important to avoid second visits to the hospital for the sole purpose of procuring tissue with optimal tumor cellularity
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