Safety of Lung Cryobiopsy in People With Cancer

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04548830
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 35.7
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Procedure: Transbronchial cryobiopsy	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: This is a single center investigator initiated study for patients who display indeterminant pulmonary nodules and diffuse parenchymal lung disease on CT chest imaging who have been referred to the Pulmonary service.This is a single center investigator initiated study for patients who display indeterminant pulmonary nodules and diffuse parenchymal lung disease on CT chest imaging who have been referred to the Pulmonary service.
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Safety of Transbronchial Cryobiopsy in a Cancer Population
• Actual Study Start Date: Sep 8, 2020
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.

Outcome Measures

Primary Outcome Measures

1. Post Cryobiopsy complications [2 years]

   will be graded according to Common Terminology Criteria for Adverse Events version 5 (CTCAE v5)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York	United States	10065

Sponsors and Collaborators

• Memorial Sloan Kettering Cancer Center

Investigators

• Principal Investigator: Bryan Husta, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Memorial Sloan Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT04548830
• Other Study ID Numbers: 20-374
• First Posted: Sep 16, 2020
• Last Update Posted: Jun 28, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Memorial Sloan Kettering Cancer Center: Cryobiopsy; 20-374

Study Results

No Results Posted as of Jun 28, 2022