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OpenTrials
Completed

NCT Number: NCT03376971

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Arizona

Tucson, Arizona, 85724, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Biopsy

Procedure

Undergo lung biopsy

Other names: Bx

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Diagnosis of ex vivo tissue samples for lung cancer or benign lesions using optical microscopy

    Time frame: 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.

  2. Imaging of ex vivo tissue samples using an endoscopic instrument

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

Real-Time Optical Biopsy for Improved Lung Cancer Diagnosis

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Dec 19, 2017
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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