Safety of Lung Cryobiopsy in People With Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT04548830
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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.
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Patients with pulse oximetry less than 92% on oxygen delivery up to 2 L nasal cannula.
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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.
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Any patient deemed unfit to undergo bronchoscopy by the proceduralist
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Female patients with a positive pregnancy test within 30 days of the planned study procedure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Post Cryobiopsy complications 2 years will be graded according to Common Terminology Criteria for Adverse Events version 5 (CTCAE v5)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)🇺🇸New York, New York, United States