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

NCT03376971 | Completed DMC

• 1 other identifier: 1706540415
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lesion; Lung Cancer; Diagnoses Disease

Keywords

Lesion; Lung; Cancer; Diagnosis; Optical Biopsy; Biopsy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Diagnostic (lung biopsy)

EXPERIMENTAL

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.

Procedure: Biopsy; Other: Laboratory Biomarker Analysis

Interventions

Biopsy PROCEDURE

Undergo lung biopsy

Also known as: Bx

Diagnostic (lung biopsy)

Laboratory Biomarker Analysis OTHER

Correlative studies

Diagnostic (lung biopsy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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.)

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

The University of Arizona

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Neoplasms; Disease

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Andrew Rouse, PhD

  The University of Arizona

  PRINCIPAL INVESTIGATOR

• Gregory Woodhead, MD

  The University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 19, 2017
• Study Start: July 26, 2017
• Primary Completion: April 26, 2022
• Study Completion: April 26, 2022
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

US (1)