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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05393154
Recruitment Status : Recruiting
First Posted : May 26, 2022
Last Update Posted : May 26, 2022
Sponsor:
Collaborators:
Johnson & Johnson
Boston University
Fox Chase Cancer Center
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Lung Cancer Device: Biopsy Adequacy Evaluation by Aquyre Biopsy Scanner

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.

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Denise Fine 781-336-8755 denise.fine@bmc.org
Contact: Austin Potter 617-901-7072 austin.potter@bmc.org

Locations
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United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Denise Fine    781-336-8755    denise.fine@bmc.org   
Contact: Austin Potter    617-901-7072    austin.potter@bmc.org   
Sponsors and Collaborators
Aquyre Bioscience, Inc
Johnson & Johnson
Boston University
Fox Chase Cancer Center
Investigators
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Principal Investigator: Ehab Billatos, MD Boston Medical Center
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Responsible Party: Aquyre Bioscience, Inc
ClinicalTrials.gov Identifier: NCT05393154    
Other Study ID Numbers: HEATMAP Lung Biopsy Study
First Posted: May 26, 2022    Key Record Dates
Last Update Posted: May 26, 2022
Last Verified: May 2022

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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
Keywords provided by Aquyre Bioscience, Inc:
Lung Biopsy