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

Primary Purpose

Lesion, Lung Cancer, Diagnoses Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biopsy
Laboratory Biomarker Analysis
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lesion focused on measuring Lesion, Lung, Cancer, Diagnosis, Optical Biopsy, Biopsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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. Hennemeyer 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 prisoners, pregnant women, patients with a contraindication for additional lung biopsies, and patients who cannot give informed consent (language barrier, cognitive impairment, etc.)

Sites / Locations

  • The University of ArizonaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (lung biopsy)

Arm 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 13, 2017
Last Updated
August 11, 2023
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT03376971
Brief Title
Real-Time Optical Biopsy in Improving Lung Cancer Diagnosis in Patients Undergoing Lung Biopsy
Official Title
Real-Time Optical Biopsy for Improved Lung Cancer Diagnosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2017 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lesion, Lung Cancer, Diagnoses Disease
Keywords
Lesion, Lung, Cancer, Diagnosis, Optical Biopsy, Biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (lung biopsy)
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Biopsy
Other Intervention Name(s)
Bx
Intervention Description
Undergo lung biopsy
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Diagnosis of ex vivo tissue samples for lung cancer or benign lesions using optical microscopy
Description
The aim is to show that it is possible to distinguish lung cancer from benign lesions in ex vivo tissue samples using optical microscopy.
Time Frame
At the time of biopsy
Title
Imaging of ex vivo tissue samples using an endoscopic instrument
Description
A proof-of-concept endoscopic instrument will be tested for imaging through a biopsy needle under computed tomography guidance on ex vivo tissue samples.
Time Frame
At the time of biopsy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Rouse, PhD
Phone
520-626-5894
Email
rouse@email.arizona.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Rouse, PhD
Organizational Affiliation
The University of Arizona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gregory Woodhead, MD
Organizational Affiliation
The University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Rouse, PhD
Phone
520-626-5894
Email
rouse@email.arizona.edu
First Name & Middle Initial & Last Name & Degree
Andrew Rouse, PhD
First Name & Middle Initial & Last Name & Degree
Gregory Woodhead, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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