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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03376971
Other study ID # 1706540415
Secondary ID 1706540415
Status Recruiting
Phase N/A
First received
Last updated
Start date July 26, 2017
Est. completion date August 31, 2025

Study information

Verified date August 2023
Source University of Arizona
Contact Andrew Rouse, PhD
Phone 520-626-5894
Email rouse@email.arizona.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This pilot early phase I trial studies how well real-time optical biopsy works in improving lung cancer diagnosis in patients undergoing lung biopsy. Real-time optical biopsy using confocal microscopy may improve the ability of physicians to diagnose lung cancer and accurately differentiate cancerous and benign lesions found during computed tomography screening.


Description:

PRIMARY OBJECTIVES: I. Show that it is possible to distinguish lung cancer from benign lesions in ex vivo tissue samples using optical microscopy. II. Test a proof-of-concept endoscopic instrument for imaging through a biopsy needle under computed tomography (CT) guidance on ex vivo tissue samples. OUTLINE: Patients undergo extraction of up to 3 additional lung biopsies from target lesions that are at least 2-3 cm in diameter using the 19 gauge SuperCore biopsy needle or the 20 gauge Rotax needle. The extracted tissue is imaged via confocal fluorescence microscopy using a variety of fluorescent contrast agents, such as, fluorescein sodium, methylene blue, or indocyanine green and then undergo hematoxylin and eosin processing.


Recruitment information / eligibility

Status Recruiting
Enrollment 23
Est. completion date August 31, 2025
Est. primary completion date August 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participants will be drawn from the pool of patients who have suspicious lesions identified on CT and who are already scheduled for a lung biopsy procedure with Dr. Woodhead or one of his colleagues - Patients will be asked to consent to 2 to 3 extra biopsy samples to be used for this research project Exclusion Criteria: - Excluded from this study will be minors below age 18, prisoners, pregnant women, patients with a contraindication for additional lung biopsies, and patients who cannot give informed consent (language barrier, cognitive impairment, etc.)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Biopsy
Undergo lung biopsy
Other:
Laboratory Biomarker Analysis
Correlative studies

Locations

Country Name City State
United States The University of Arizona Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnosis of ex vivo tissue samples for lung cancer or benign lesions using optical microscopy The aim is to show that it is possible to distinguish lung cancer from benign lesions in ex vivo tissue samples using optical microscopy. At the time of biopsy
Primary Imaging of ex vivo tissue samples using an endoscopic instrument A proof-of-concept endoscopic instrument will be tested for imaging through a biopsy needle under computed tomography guidance on ex vivo tissue samples. At the time of biopsy
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