Comparing biopsy methods for lung transplant rejection diagnosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Research on improving outcomes for lung transplant donors and recipients

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• Evaluating extracorporeal photopheresis for subclinical lung transplant rejection

  This study is testing if a light-based treatment called extracorporeal photopheresis can help lung transplant patients who have early signs of rejection feel better and improve their health.

  Recruiting Medical University of Vienna · Vienna and 6 other locations · NCT06112951

• Testing the effectiveness of belumosudil for treating lung transplant rejection

  This study is testing if belumosudil can help improve lung function in adults who have had a lung transplant and are experiencing ongoing issues with their new lungs.

  Recruiting at 81 sites Phase 3 Sanofi · Birmingham, Alabama and 84 other locations · NCT06082037

• Identifying biomarkers for lung transplant dysfunction

  This study is trying to find specific markers in the body that can help doctors understand and manage problems after lung transplants for patients at Foch Hospital.

  Recruiting Hopital Foch · Suresnes · NCT04837339

• Evaluating new diagnostic methods for lung transplant rejection

  This study is testing a new diagnostic tool to see if it can better identify lung transplant rejection in patients who are having problems with their transplanted lungs.

  Recruiting at 4 sites University of Alberta · Phoenix, Arizona and 10 other locations · NCT02812290

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.