Clinical trial · Interventional
Safety of Lung Cryobiopsy in People With Cancer
Safety of Transbronchial Cryobiopsy in a Cancer Population
NCT04548830CI-TRIAL-00116580completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to find out whether a biopsy technique called transbronchial cryobiopsy (TBCB) is a safe alternative to the standard biopsy procedure (transbronchial forceps biopsy; TBFB). The study researchers think that TBCB may provide better biopsy samples to help diagnose lung disease.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transbronchial cryobiopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Transbronchial cryobiopsy
- description
- 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.
- interventionNames
- Procedure: Transbronchial cryobiopsy
Primary outcomes (1)
- measure
- Post Cryobiopsy complications
- timeFrame
- 2 years
- description
- will be graded according to Common Terminology Criteria for Adverse Events version 5 (CTCAE v5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or greater * 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. Exclusion Criteria: * Patients with pulse oximetry less than 92% on oxygen delivery up to 2 L nasal cannula. * Uncorrectable coagulopathy defined as: * Platelet count \<50,000 x 10\^9/L or * prothrombin time international normalized ratio \>1.5 * Known pulmonary hypertension or echocardiographic pulmonary artery systolic pressure \>50mmHg * A secure diagnosis based on clinical and high-resolution CT scan data. * Antiplatelet therapy that cannot be held for more than 5 days. * Any patient deemed unfit to undergo bronchoscopy by the proceduralist * Female patients with a positive pregnancy test within 30 days of the planned study procedure
References
Publications (1)
- DERIVEDHusta BC, Ganjaei KG, Knezevic A, Aly RG, Fanaroff R, Lee RP, Bott MJ, Oberg CL, Travis WD, Chawla M, Kalchiem-Dekel O. A Prospective Study of Safety and the Incremental Diagnostic Value of Transbronchial Cryobiopsy Incorporated into Robotic-Assisted Bronchoscopy in a Cancer Population. Lung. 2025 Dec 18;204(1):1. doi: 10.1007/s00408-025-00863-x. PMID 41413664