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NCT04548830 Clinical Trial

Safety of Lung Cryobiopsy in People With Cancer

Lung Cancer Clinical Trial

Official title:
Safety of Transbronchial Cryobiopsy in a Cancer Population

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04548830
Other study ID # 20-374
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date September 8, 2020
Est. completion date September 2025

Study information
Verified date August 2023
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 100
Est. completion date September 2025
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 - 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Transbronchial cryobiopsy
After enrollment, and pre-treatment procedures are complete, patients will undergo flexible bronchoscopy with a therapeutic bronchoscope under general anesthesia via an advanced airway at Memorial Hospital in an inpatient or outpatient setting.

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Post Cryobiopsy complications will be graded according to Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) 2 years
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