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Safety of Lung Cryobiopsy in People With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04548830
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : November 15, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Safety of Transbronchial Cryobiopsy in a Cancer Population
Actual Study Start Date : September 8, 2020
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Post Cryobiopsy complications [ Time Frame: 2 years ]
    will be graded according to Common Terminology Criteria for Adverse Events version 5 (CTCAE v5)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04548830


Contacts
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Contact: Bryan Husta, MD 212-639-5448 hustab@mskcc.org
Contact: Jason Beattie, MD 212-639-7843

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center (All Protocol Activities) Recruiting
New York, New York, United States, 10065
Contact: Bryan Husta, MD    212-639-5448      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Bryan Husta, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04548830    
Other Study ID Numbers: 20-374
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: November 15, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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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