← Back to all trials
Completed
NCT04548830
Safety of Lung Cryobiopsy in People With Cancer
Conditions: Lung Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 115
Sponsor: Memorial Sloan Kettering Cancer Center
Location: Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York
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.
Eligibility 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 \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
Source: ClinicalTrials.gov (NCT04548830). StuddyBuddy aggregates publicly available trial information.