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NCT06105801: FROSTBITE-3
EBUS-TBNA vs Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing
Phase 4 trial testing Endobronchial ultrasound with transbronchial needle aspiration in Lung Cancer in 250 participants. Currently enrolling.
31 October 2027
Quick facts
| Lead sponsor | Vanderbilt-Ingram Cancer Center |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | diagnostic |
| Enrollment | 250 |
| Start date | 13 September 2024 |
| Primary completion | 31 October 2027 |
| Estimated completion | 31 October 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Endobronchial ultrasound with transbronchial needle aspiration
- Bronchoscopy
- Cryobiopsy
Conditions studied
- Lung Cancer — all drugs for Lung Cancer →
Sponsor
Vanderbilt-Ingram Cancer Center — full company profile →
Who can join
18 and older, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06105801
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06105801 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vanderbilt-Ingram Cancer Center
- Last refreshed: 2 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06105801.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing