Real-Time Optical Biopsy in Improving Lung Cancer Diagnosis in Patients Undergoing Lung Biopsy

Lung Cancer Clinical Trial

Official title:

Real-Time Optical Biopsy for Improved Lung Cancer Diagnosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03376971
• Other study ID #: 1706540415
• Secondary ID: 1706540415
• Status: Recruiting
• Phase: N/A
• 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
• 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.)

Related Conditions & MeSH terms

• Diagnoses Disease
• Disease
• Lesion
• Lung Cancer
• Lung Neoplasms

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