Status:
UNKNOWN
Pilot Study of Biopsy Scanner for Evaluation of Bronchoscopic Small Biopsy Specimens to Determine Adequacy
Lead Sponsor:
Aquyre Bioscience, Inc
Collaborating Sponsors:
Johnson & Johnson
Boston University
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The aim of the study is to assess the performance of Aquyre Biopsy Scanner technology (the FDA class I medical device) at determining if tissue from the lymph nodes and lung nodules, taken during a br...
Detailed Description
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. Th...
Eligibility Criteria
Inclusion
- Signed informed consent prior to initiation of any study procedures.
- Patient has a radiographically identified lung lesion(s) suspicious for malignancy and requiring histopathologic diagnosis.
- Patient with a previously obtained (within 3 months) CT image showing at least one solid lesion equal to or greater than 1 cm in diameter or at least one semisolid lesion with a solid component of equal to or greater than 1 cm in diameter.
- Bronchoscopic biopsy procedure is planned for the above lesion(s).
Exclusion
- Patient does not meet the requirements to undergo biopsy as determined by the treating physician.
- Patient is unable to provide a signed informed consent to participate in the study.
- Patient has only ground glass lesion(s) that do not have a solid component.
Key Trial Info
Start Date :
September 22 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05393154
Start Date
September 22 2021
End Date
September 1 2022
Last Update
May 26 2022
Active Locations (1)
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1
Boston Medical Center
Boston, Massachusetts, United States, 02118