Clinical trial · Interventional
Cryobiopsy Versus Forceps Biopsy for Pulmonary Lesions
An Un-blinded, Intra-patient Comparison of Transbronchial Forceps Biopsy and Cryobiopsy for Peripheral Pulmonary Lesions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Interim analysis also showed a lack of benefit in the experimental arm.
Summary
Brief summary (as posted)
Purpose: Patients with peripheral lung nodules require evaluation for lung cancer. Our aim is to assess the diagnostic yield of a new technique, transbronchial cryobiopsies, in patients at risk for lung cancer. Target population: Patients referred for bronchoscopy and lung biopsies as a part of their work up for peripheral lung lesions. Procedures: Patients enrolled will have forceps transbronchial biopsies followed by transbronchial cryobiopsies for their lung lesion during bronchoscopy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Pulmonary Nodules | — | UNRESOLVED | — |
| Solitary Pulmonary Nodule | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| transbronchial biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single intervention arm - transbronchial biopsy
- description
- Patients enrolled in this single arm study will have lung nodules biopsied by traditional forceps followed by transbronchial cryobiopsy
- interventionNames
- Procedure: transbronchial biopsy
Primary outcomes (1)
- measure
- The increase in sensitivity for diagnosing lung cancer with the addition of cryobiopsy to standard forceps biopsy for a suspicious lung nodule.
- timeFrame
- 1 year
- description
- Sensitivity for cancer is defined as true positives / (true positives + false negatives) with respect to diagnosing malignancy. If the bronchoscopic procedure fails to diagnose malignancy, the gold standard will be the results of any further, more invasive testing that is clinically indicated to evaluate the nodule.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \>/= 18 2. At least one peripheral lung lesion \>8mm documented on CT scan referred for diagnostic bronchoscopy 3. Subject is able to undergo informed consent Exclusion Criteria: 1. Coagulopathy (platelet count \< 50,000, INR \> 1.5) detected on blood testing done within 6 weeks of the procedural visit 2. Lesion associated with a prominent vessel evident on CT scan 3. Pure ground glass lesion 4. Fibrotic interstitial lung abnormalities on chest CT 5. Bullous emphysema in region of nodule 6. Supplemental oxygen utilization at baseline 7. BMI \> 40 8. End stage renal disease
References
Publications (0)
Data not yet available