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

May 24, 2022 updated by: Aquyre Bioscience, Inc

Pilot Study of Biopsy Scanner for Evaluation of Bronchoscopic Small Biopsy Specimens

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Tissue will be collected from patients with radiographically identified lung lesions suspicious for cancer for whom a biopsy is being performed for pathological diagnosis, as determined by the investigator.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Participant
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aquyre Bioscience, Inc

Collaborators

Boston University
Fox Chase Cancer Center
Johnson & Johnson

Investigators

  • Principal Investigator: Ehab Billatos, MD, Boston Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2021

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

May 3, 2022

First Submitted That Met QC Criteria

May 24, 2022

First Posted (Actual)

May 26, 2022

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HEATMAP Lung Biopsy Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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