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

University of Arizona

Status: Suspended

Conditions: Lung Cancer; Diagnoses Disease; Lesion

Treatments: Other: Laboratory Biomarker Analysis; Procedure: Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT03376971

1706540415 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

23 participants in 1 patient group

Diagnostic (lung biopsy)

Experimental group

Description:

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, indocyanine green and then undergo hematoxylin and eosin processing.

Treatment:

Procedure: Biopsy

Other: Laboratory Biomarker Analysis