Cryobiopsy Versus Forceps Biopsy for Pulmonary Lesions

NCT02983903 | Terminated

• 1 other identifier: IRB # 825506
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: Patients with peripheral lung nodules require evaluation for lung cancer. Our aim is to assess the diagnostic yield of a new technique, transbronchial cryobiopsies, in patients at risk for lung cancer. Target population: Patients referred for bronchoscopy and lung biopsies as a part of their work up for peripheral lung lesions. Procedures: Patients enrolled will have forceps transbronchial biopsies followed by transbronchial cryobiopsies for their lung lesion during bronchoscopy.

Conditions

Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Outcome Measures

Primary Outcomes (1)

• The increase in sensitivity for diagnosing lung cancer with the addition of cryobiopsy to standard forceps biopsy for a suspicious lung nodule.

  Sensitivity for cancer is defined as true positives / (true positives + false negatives) with respect to diagnosing malignancy. If the bronchoscopic procedure fails to diagnose malignancy, the gold standard will be the results of any further, more invasive testing that is clinically indicated to evaluate the nodule.

  1 year

Secondary Outcomes (2)

• The increase in sensitivity for diagnosing a specific benign lung disease with the addition of cryobiopsy to standard forceps biopsy for a suspicious lung nodule.

  1 year

• The number of participants with pneumothorax or significant bleeding related to the addition of transbronchial cryobiopsy to standard forceps biopsy.

  1 year

Study Arms (1)

Single intervention arm - transbronchial biopsy

EXPERIMENTAL

Patients enrolled in this single arm study will have lung nodules biopsied by traditional forceps followed by transbronchial cryobiopsy

Procedure: transbronchial biopsy

Interventions

transbronchial biopsy PROCEDURE

Single intervention arm - transbronchial biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>/= 18
• At least one peripheral lung lesion \>8mm documented on CT scan referred for diagnostic bronchoscopy
• Subject is able to undergo informed consent

You may not qualify if:

• Coagulopathy (platelet count \< 50,000, INR \> 1.5) detected on blood testing done within 6 weeks of the procedural visit
• Lesion associated with a prominent vessel evident on CT scan
• Pure ground glass lesion
• Fibrotic interstitial lung abnormalities on chest CT
• Bullous emphysema in region of nodule
• Supplemental oxygen utilization at baseline
• BMI \> 40
• End stage renal disease

Sponsors & Collaborators

• University of Pennsylvania: lead
• Andrew Haas: collaborator
• Anil Vachani: collaborator
• Anthony Lanfranco: collaborator
• Kevin Ma: collaborator
• Jeffrey Thompson: collaborator
• Edmund Moon: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

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

Study Officials

• David M DiBardino, MD

  University of Pennslyvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine, Section of Interventional Pulmonology and Thoracic Oncology, Assistant Professor of Medicine at the Hospital of the University of Pennsylvania

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: December 6, 2016
• Study Start: November 1, 2016
• Primary Completion: March 2, 2020
• Study Completion: March 2, 2020
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)