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OpenTrials
Completed

NCT Number: NCT04548830

Safety of Lung Cryobiopsy in People With Cancer

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

Transbronchial cryobiopsy

Procedure

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.

Primary outcomes

  1. Post Cryobiopsy complications

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Safety of Transbronchial Cryobiopsy in a Cancer Population

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2020
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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