Rochester, Minnesota 55905


Purpose:

Can neoadjuvant intrapleural cryotherapy be safely performed in patients with malignant pleural mesothelioma and will it trigger substantial systemic and local pro-inflammatory changes, resulting in the induction of anti-tumor immunity?


Study summary:

Patients that have been diagnosed, or are suspected of having malignant pleural mesothelioma, a cancer of the pleura, surgery may be considered as an attempt to treat the cancer. As part of the testing needed before surgery, a pleuroscopy or video camera examination of the pleura is necessary to establish the diagnosis and/or to evaluate the extent of the cancer. This study evaluates the effects of cryotherapy (freezing spray) on the ability of a patient's immune system to attack the cancer, as has been reported in other types of cancers. The purpose of this research is to gather information on the safety and effectiveness of cryotherapy in patients with malignant pleural mesothelioma. If successful, this study could provide support for future studies evaluating this new treatment for mesothelioma.


Criteria:

Inclusion Criteria - Subject provides informed consent - Subject is >18 years of age - Subject is deemed competent for making medical decisions - Subject is scheduled to undergo pleuroscopy as part of their standard care for pre-operative clinical staging of malignant pleural mesothelioma - A negative pregnancy test is required in women of child-bearing potential, as standard of care. - Subject is mentally capable of understanding study procedures. Exclusion Criteria Study subject has any disease or condition that interferes with safe completion of the study including: - Platelet count < 50K, coagulopathy defined as an International Normalized Ratio (INR) > 1.5 - Anticoagulants such as clopidogrel, heparin, low-molecular weight heparin, warfarin or other novel anticoagulants have not been held for the standard time period published - Hemodynamic instability with systolic blood pressure <90 mmHg or heart rate > 120 beats/min, unless deemed to be stable with these values by the surgical or interventional pulmonary attending physicians. - Hypoxemia with pulse oximetry values <88% or partial pressure of oxygen in arterial blood (PaO2) < 60 on baseline oxygen requirements. - Concurrent participation in another study involving investigational drugs or investigational medical devices - Absence of or limited access to the pleural space during medical pleuroscopy. - Inability to read and understand the necessary study documents.


NCT ID:

NCT02464904


Primary Contact:

Principal Investigator
Shanda H Blackmon, MD, MPH
Mayo Clinic

Karlyn Pierson, RN, MAN
Phone: 507-538-1960
Email: pierson.karlyn@mayo.edu


Backup Contact:

Email: lechtenberg.bettie@mayo.edu
Bettie Lechtenberg, MBA
Phone: 507-266-4819


Location Contact:

Rochester, Minnesota 55905
United States

Karlyn Pierson, RN, MAN
Phone: 507-538-1960
Email: pierson.karlyn@mayo.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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