Safety of Lung Cryobiopsy in People With Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 2

Conditions: Lung Cancer

Treatments: Procedure: Transbronchial cryobiopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04548830

20-374

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Transbronchial cryobiopsy

Experimental group

Description:

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.

Treatment:

Procedure: Transbronchial cryobiopsy