Comparing biopsy methods for lung transplant rejection diagnosis
A Prospective, Randomized Clinical Trial to Evaluate the Feasibility of Miniature Cryoprobe Biopsy to Detect Acute and Chronic Lung Transplant Rejection in Lung Transplant Recipients
This study tests which of two methods for taking lung tissue samples works better for diagnosing rejection in lung transplant patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06824402 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of two biopsy collection methods, a 1.1 mm cryoprobe and biopsy forceps, in diagnosing lung transplant rejection. Participants will be randomly assigned to receive one of the two methods during their scheduled bronchoscopy. The study will assess the quality of tissue samples, the adequacy of tissue collected, and the procedural time required for each method. Additionally, pathologists will evaluate the samples to determine which method provides the most reliable results for detecting rejection.
Who should consider this trial
Good fit: Ideal candidates are lung transplant recipients over 18 years old who require a post-transplant biopsy for routine surveillance.
Not a fit: Patients with bleeding disorders or those currently on anticoagulation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy for lung transplant rejection, enhancing patient management.
How similar studies have performed: Other studies have explored various biopsy techniques in transplant settings, but this specific comparison of cryoprobe versus forceps is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Male and female lung transplant recipients age \>18 at the time of informed consent * Patients clinically meet indication for post-transplant lung biopsy or planned routine surveillance and have been scheduled for bronchoscopy with transbronchial biopsy. * Be willing and able to sign the informed consent. Exclusion Criteria * Patients with known bleeding diathesis * Platelet count \<50,000 per μL within 14 days of the biopsy procedure * Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable) * Inability or unwillingness to give informed consent or study procedures * Pregnant or nursing females, or females who intend to become pregnant * Females of child-bearing potential who decline a pregnancy test prior to enrollment * If an investigator does not feel that this study is in the subject's best interest or would be a good fit for the study. * International Normalized Ratio (INR) \>1.5 * Do Not Resuscitate (DNR) status * Do Not Intubate (DNI) status * Single lung transplant recipients
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: John Joerns — Mayo Clinic
- Study coordinator: John Joerns, MD
- Email: joerns.john@mayo.edu
- Phone: 507-284-6616
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.