NCT04548830

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_2 lung-cancer

Timeline
16mo left

Started Sep 2020

Longer than P75 for phase_2 lung-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Sep 2020Sep 2027

First Submitted

Initial submission to the registry

September 8, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

September 8, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

7 years

First QC Date

September 8, 2020

Last Update Submit

April 30, 2026

Conditions

Lung Cancer

Keywords

Cryobiopsy20-374

Outcome Measures

Primary Outcomes (1)

  • Post Cryobiopsy complications

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

    2 years

Study Arms (1)

Transbronchial cryobiopsy

EXPERIMENTAL

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

Interventions

Transbronchial cryobiopsyPROCEDURE

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.

Transbronchial cryobiopsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Related Publications (1)

  • Husta BC, Ganjaei KG, Knezevic A, Aly RG, Fanaroff R, Lee RP, Bott MJ, Oberg CL, Travis WD, Chawla M, Kalchiem-Dekel O. A Prospective Study of Safety and the Incremental Diagnostic Value of Transbronchial Cryobiopsy Incorporated into Robotic-Assisted Bronchoscopy in a Cancer Population. Lung. 2025 Dec 18;204(1):1. doi: 10.1007/s00408-025-00863-x.

    PMID: 41413664DERIVED

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Or Kalchiem-Dekel, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2020

First Posted

September 16, 2020

Study Start

September 8, 2020

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Locations

US(1)