Safety of Lung Cryobiopsy in People With Cancer

Phase 2

Active, not recruiting

• Conditions: Lung Cancer
• Interventions: Procedure: Transbronchial cryobiopsy

• Registration Number: NCT04548830
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-09-08
• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

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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

• FVC <50% of the predicted value, DLCO <30% of the predicted value or FEV1 <0.8L

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transbronchial cryobiopsy	Transbronchial cryobiopsy	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.

Primary Outcome Measures

Name	Time	Method
Post Cryobiopsy complications	2 years	will be graded according to Common Terminology Criteria for Adverse Events version 5 (CTCAE v5)

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States