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
• Status: Active, not recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Lung Cancer

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

External Links

•   Memorial Sloan Kettering Cancer Center