Pilot Study of Biopsy Scanner for Evaluation of Bronchoscopic Small Biopsy Specimens to Determine Adequacy
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|ClinicalTrials.gov Identifier: NCT05393154|
Recruitment Status : Recruiting
First Posted : May 26, 2022
Last Update Posted : May 26, 2022
|Condition or disease||Intervention/treatment|
|Lung Cancer||Device: Biopsy Adequacy Evaluation by Aquyre Biopsy Scanner|
In this study, lymph node or lung nodule tissue will be collected by bronchoscopy as part of standard clinical care. The tissue is being collected to help make a diagnosis of a pulmonary condition. The same amount of tissue that is collected per standard of care for diagnosis will be collected during the study; no additional tissue is taken for this study. The biopsy sample will be analyzed by the Aquyre Biopsy Scanner which will provide images of unprocessed lung biopsy tissue taken during your procedure. A pathologist will also analyze the tissue sample in accordance with existing clinical guidelines. The doctor will use the pathology results to help make a diagnosis of your condition. The results of the Aquyre Biopsy Scanner analysis will be compared to the pathology results. This will help determine how well the Aquyre Biopsy Scanner performs in identifying tissue samples that are suitable for pathology analysis and those that are not. The comparison between Aquyre Biopsy Scanner and the pathology analysis is the experimental part of the study.
The tissue will not be collected specifically for study purposes. Rather, the tissue will be collected as part of the existing clinical care. The same amount of tissue that is collected per standard of care for diagnosis will be collected during the study, the study does not require additional tissue. In addition, the biopsy samples will be divided so the evaluation of the tissue by the pathologist will also be performed, which is part of standard clinical care.
The Aquyre microscope is non-destructive, therefore the tissue samples will be available for subsequent pathology analysis using standard techniques. The experimental part of this study is to compare the images from the microscope to the reading/diagnosis from the pathologist.
NOTE: According to NIH definition, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4083571/ this is an observational study design, which evaluate the accuracy of diagnostic procedures and tests as compared to other diagnostic measures. Diagnostic results of the Aquyre microscope are used for observational comparison only, and not used to direct or change patient care.
|Study Type :||Observational|
|Estimated Enrollment :||70 participants|
|Official Title:||Pilot Study of Biopsy Scanner for Evaluation of Bronchoscopic Small Biopsy Specimens|
|Actual Study Start Date :||September 22, 2021|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||September 2022|
Non-destructive imaging of biopsies using the Aquyre system
Device: Biopsy Adequacy Evaluation by Aquyre Biopsy Scanner
Microscopic viewing and imaging of Bronchoscopic Biopsy Specimens using Full Field Optical Coherence Tomography and Dynamic Cell Imaging
- The performance characteristics (sensitivity, specificity, PPV, and NPV) will be calculated for the Aquyre Biopsy Scanner image relative to Pathology. [ Time Frame: through study completion, an average of 1 year ]Evaluation of Aquyre Biopsy images by the bronchoscopist to determine biopsy adequacy comparing to results of pathology.
- Test characteristics will be calculated for the ROSE slides relative to Pathology. [ Time Frame: through study completion, an average of 1 year ]Evaluation of Aquyre Biopsy images by the bronchoscopist to determine biopsy adequacy comparing to results of ROSE slides
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05393154
|Contact: Denise Fineemail@example.com|
|Contact: Austin Potterfirstname.lastname@example.org|
|Principal Investigator:||Ehab Billatos, MD||Boston Medical Center|