Intrapleural Cryotherapy for Malignant Pleural Mesothelioma
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|ClinicalTrials.gov Identifier: NCT02464904|
Recruitment Status : Terminated (Difficulty enrolling patients due to enrollment criteria.)
First Posted : June 8, 2015
Last Update Posted : February 9, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Mesothelioma||Procedure: Cryotherapy Other: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study Evaluating the Effects of Intrapleural Cryotherapy on Tumor Infiltrating Lymphocytes in Malignant Pleural Mesothelioma Using Cryospray Therapy|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||February 26, 2021|
|Actual Study Completion Date :||February 26, 2021|
Cryospray and biopsies
Subjects will have their blood drawn prior to undergoing a staging pleuroscopy. During the pleuroscopy pleural fluid will be collected as well as pleural biopsies (4 to 8 research biopsies). The procedure will involve 2 to 3 applications of cryospray on the location of the disease. After establishing cryofrost over a minimum of a 2 x 2 cm area, cryospray will continue for 15 to 20 seconds, allow a thaw period of 60 seconds followed by one to two repeats in the same location before proceeding onto the next location. We will treat a minimum of 6 x 6 cm area in aggregate. The freezing procedure will be video-recorded and freezing locations and time will be recorded. Approximately, 14 days following the staging pleuroscopy patients will undergo surgical treatment as per standard of care, with repeat blood, pleural fluid and tissue collection.
Subjects will have their blood drawn prior to undergoing a staging pleuroscopy. During the pleuroscopy pleural fluid will be collected as well as pleural biopsies (4 to 8 research biopsies). Approximately, 14 days following the staging pleuroscopy patients will undergo surgical treatment as per standard of care, with repeat blood, pleural fluid and tissue collection
- Number of Participants with Adverse Events [ Time Frame: 1 month ]Participants will be monitored for any adverse events that may have resulted from the pleuroscopy procedure.
- Mean Number of Tumor Infiltrating Immune Cells as Measured by Immunohistochemistry on Participant Tissue Samples [ Time Frame: 14 days ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464904
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Shanda H Blackmon, MD, MPH||Mayo Clinic|
|Responsible Party:||Shanda Blackmon, M.D., M.P.H., PI, Mayo Clinic|
|Other Study ID Numbers:||
|First Posted:||June 8, 2015 Key Record Dates|
|Last Update Posted:||February 9, 2022|
|Last Verified:||January 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases