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

NCT05393154 | Unknown FDA Device

• 1 other identifier: HEATMAP Lung Biopsy Study
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Lung Biopsy

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

• Test characteristics will be calculated for the ROSE slides relative to Pathology.

  through study completion, an average of 1 year

Study Arms (1)

Study Participant

Non-destructive imaging of biopsies using the Aquyre system

Device: Biopsy Adequacy Evaluation by Aquyre Biopsy Scanner

Interventions

Biopsy Adequacy Evaluation by Aquyre Biopsy Scanner DEVICE

Microscopic viewing and imaging of Bronchoscopic Biopsy Specimens using Full Field Optical Coherence Tomography and Dynamic Cell Imaging

Study Participant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aquyre Bioscience, Inc: lead
• Johnson & Johnson: collaborator
• Boston University: collaborator
• Fox Chase Cancer Center: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ehab Billatos, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise Fine

CONTACT

781-336-8755; denise.fine@bmc.org

Austin Potter

CONTACT

617-901-7072; austin.potter@bmc.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 26, 2022
• Study Start: September 22, 2021
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: May 26, 2022

Record last verified: 2022-05

Locations

US (1)