Pilot Study of Biopsy Scanner for Evaluation of Bronchoscopic Small Biopsy Specimens to Determine Adequacy

• Conditions: Lung Cancer
• Interventions: Device: Biopsy Adequacy Evaluation by Aquyre Biopsy Scanner

• Registration Number: NCT05393154
• Lead Sponsor: Aquyre Bioscience, Inc

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 bronchoscopy procedure, is adequate for a diagnosis. The study will assess how well the Aquyre Biopsy Scanner can differentiate between tissue samples that meet certain requirements that allow for further diagnostic analysis and samples that do not.

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. 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 Timeline

• Study Start: 2021-09-22
• Status Verified: 2022-05
• Study First Submitted: 2022-05-03
• Study First Submitted QC: 2022-05-24
• Last Update Submitted: 2022-05-24
• Study First Posted: 2022-05-26
• Last Update Posted: 2022-05-26
• Primary Completion: 2022-08
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Signed informed consent prior to initiation of any study procedures.
2. Patient has a radiographically identified lung lesion(s) suspicious for malignancy and requiring histopathologic diagnosis.
3. 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.
4. Bronchoscopic biopsy procedure is planned for the above lesion(s).

Exclusion Criteria

1. Patient does not meet the requirements to undergo biopsy as determined by the treating physician.
2. Patient is unable to provide a signed informed consent to participate in the study.
3. Patient has only ground glass lesion(s) that do not have a solid component.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Participant	Biopsy Adequacy Evaluation by Aquyre Biopsy Scanner	Non-destructive imaging of biopsies using the Aquyre system

Primary Outcome Measures

Name	Time	Method
The performance characteristics (sensitivity, specificity, PPV, and NPV) will be calculated for the Aquyre Biopsy Scanner image relative to Pathology.	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.

Secondary Outcome Measures

Name	Time	Method
Test characteristics will be calculated for the ROSE slides relative to Pathology.	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

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States