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Procedure
Optical Biopsy for Lung Cancer Diagnosis
N/A
Recruiting
Led By Charles Hennemeyer, MD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients will be asked to consent to 2 to 3 extra biopsy samples to be used for this research project
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the time of biopsy
Awards & highlights
Study Summary
This trial uses a new technology called optical biopsy to improve the accuracy of lung cancer diagnosis.
Who is the study for?
This trial is for adults with suspicious lung lesions identified on CT scans, who are already scheduled for a lung biopsy. They must consent to 2-3 extra samples for research and be able to give informed consent. It's not open to minors, prisoners, pregnant women, or those unable to consent due to language barriers or cognitive impairments.Check my eligibility
What is being tested?
The study is testing real-time optical biopsy using confocal microscopy during standard lung biopsies. The goal is to see if this technology can better diagnose lung cancer and distinguish between cancerous and non-cancerous lesions found in CT screenings.See study design
What are the potential side effects?
Since the intervention involves additional biopsy samples rather than medication, side effects may include typical risks associated with biopsies such as discomfort at the biopsy site, bleeding, infection risk, and very rarely collapsed lung.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to provide 2-3 extra biopsy samples for research.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the time of biopsy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the time of biopsy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Diagnosis of ex vivo tissue samples for lung cancer or benign lesions using optical microscopy
Imaging of ex vivo tissue samples using an endoscopic instrument
Trial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (lung biopsy)Experimental Treatment2 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~840
Find a Location
Who is running the clinical trial?
University of ArizonaLead Sponsor
512 Previous Clinical Trials
147,778 Total Patients Enrolled
Charles Hennemeyer, MDPrincipal InvestigatorThe University of Arizona
1 Previous Clinical Trials
10 Total Patients Enrolled
Andrew Rouse, PhDPrincipal InvestigatorThe University of Arizona
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I cannot undergo more lung biopsies due to health risks.I agree to provide 2-3 extra biopsy samples for research.Participants have suspicious spots found on a CT scan and are already scheduled for a lung biopsy with Dr. Woodhead or one of his colleagues.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (lung biopsy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still open for this experiment?
"Affirmative. Clinicaltrials.gov data suggests that this clinical trial commenced on July 26th 2017 and remains open to new enrollees, with the most recent update occurring on August 3rd 2022. At present, 23 participants are sought from 1 hospital location."
Answered by AI
What is the uppermost cap of participants that this experiment can accommodate?
"Affirmative. Clinicaltrials.gov indicates this experiment is currently enrolling volunteers, which it began to do on July 26th 2017 and last updated on August 3rd 2022. 23 participants are needed from one medical centre for the study's completion."
Answered by AI
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