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Lung Cryobiopsy Safety for Lung Cancer
Phase 2
Waitlist Available
Led By Bryan Husta, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with known or suspected diagnosis of cancer and indeterminant pulmonary nodules or diffuse parenchymal lung disease with non-diagnostic clinical profiles for whom a lung biopsy is deemed useful for diagnosis.
18 years of age or greater
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing whether a new biopsy technique, transbronchial cryobiopsy (TBCB), is a safe alternative to the standard biopsy procedure (transbronchial forceps biopsy; TBFB).
Who is the study for?
This trial is for adults with known or suspected lung cancer who need a biopsy to diagnose lung disease. It's not for those with severe pulmonary hypertension, unfit for bronchoscopy, pregnant women, low oxygen levels on minimal support, clear diagnosis from scans and tests, or serious blood clotting issues.Check my eligibility
What is being tested?
The study is testing the safety of transbronchial cryobiopsy (TBCB) compared to the standard forceps biopsy in diagnosing lung diseases. Researchers believe TBCB might provide better samples for accurate diagnoses.See study design
What are the potential side effects?
Potential side effects may include bleeding from the biopsy site, pain at the procedure area, breathing difficulties post-procedure, and risks associated with sedation used during bronchoscopy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I may have cancer and need a lung biopsy to diagnose unclear lung issues.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post Cryobiopsy complications
Trial Design
1Treatment groups
Experimental Treatment
Group I: Transbronchial cryobiopsyExperimental Treatment1 Intervention
All study participants will undergo transbronchial biopsies via our proposed standardized cryo-biopsy protocol in place of the traditional forceps transbronchial biopsy that is typically used at MSK.
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,931 Previous Clinical Trials
597,589 Total Patients Enrolled
Bryan Husta, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
150 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have high blood pressure in the lungs.I may have cancer and need a lung biopsy to diagnose unclear lung issues.My diagnosis was confirmed with a CT scan.My blood doesn't clot properly, and my lung function is significantly reduced.My oxygen levels are below 92% even with up to 2L of oxygen through a nasal tube.I am 18 years old or older.I am not pregnant or have tested negative for pregnancy within the last 30 days.I cannot stop my blood thinner medication for more than 5 days.
Research Study Groups:
This trial has the following groups:- Group 1: Transbronchial cryobiopsy
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.
Has the FDA cleared Transbronchial cryobiopsy for use?
"Transbronchial cryobiopsy falls into the category of a Phase 2 trial, which means that while there is evidence of its safety, there is no data confirming its efficacy. Power rates this procedure as a 2."
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