Bronchoscopy + Cryobiopsy for Lung Cancer
(FROSTBITE-3 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a multi-center clinical trial evaluating the effect of transbronchial mediastinal cryobiopsy for its ability to improve the likelihood of obtaining tissue sufficient for molecular analysis. Patients in outpatient clinics or pre-operative holding areas planning to undergo a bronchoscopic biopsy of a suspected malignant lesion (peripheral or mediastinal) for initial diagnosis, staging, or tissue acquisition for molecular analysis will be considered for enrollment and consented. Patients will only be enrolled if intraoperative ROSE suggests malignancy. Patients will be randomized to continue with the operator's initial EBUS-TBNA needle or switch to a cryoprobe to perform a sampling.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
Is bronchoscopy with cryobiopsy generally safe for humans?
How is the treatment Bronchoscopy + Cryobiopsy for Lung Cancer different from other treatments?
What data supports the effectiveness of the treatment Bronchoscopy + Cryobiopsy for Lung Cancer?
Research shows that using endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBCB) can improve the accuracy of lung cancer diagnosis by providing larger tissue samples compared to traditional methods. This suggests that the treatment could be more effective in diagnosing lung cancer.5671112
Who Is on the Research Team?
Fabien Maldonado, MD
Principal Investigator
Vanderbilt University/Ingram Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with suspected lung cancer who have a mediastinal lesion visible on ultrasound or PET/CT scans and malignant cells found in a quick onsite test. It's not for prisoners, those under 18, pregnant individuals, or if the doctor thinks it's unsafe to biopsy the lesion.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either EBUS-TBNA or transbronchial mediastinal cryobiopsy for tissue sampling
Follow-up
Participants are monitored for safety endpoints such as pneumothorax, bleeding, and respiratory failure within 7 days of the procedure
Long-term Follow-up
Participants' samples are evaluated for adequacy in next-generation sequencing and other exploratory endpoints
What Are the Treatments Tested in This Trial?
Interventions
- Bronchoscopy
- Cryobiopsy
- Endobronchial ultrasound with transbronchial needle aspiration
Bronchoscopy is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt-Ingram Cancer Center
Lead Sponsor
Northwestern Medicine
Collaborator
Johns Hopkins University
Collaborator
Duke University
Collaborator