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

Real-Time Optical Biopsy for Improved Lung Cancer Diagnosis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03376971

Enrollment

Registered

2017-12-19

Start date

2017-07-26

Completion date

2022-04-26

Last updated

2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnoses Disease, Lesion, Lung Cancer

Keywords

Lesion, Lung, Cancer, Diagnosis, Optical Biopsy, Biopsy

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.

Detailed 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.

Interventions

PROCEDUREBiopsy

Undergo lung biopsy

OTHERLaboratory Biomarker Analysis

Correlative studies

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.)

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026