For mesothelioma patients and families that are interested in clinical trials, researching clinical trials and eligibility can be a time-consuming barrier to participation. The information about clinical trials is available on www.clinicaltrials.gov.
Our goal is to feature one mesothelioma clinical trial monthly and break it down to understandable terms, to decipher the eligibility requirements, and to possibly encourage participation in these trials.
Clinical Trial – NCT 02464904
Official Title: Intrapleural Cryotherapy for Malignant Pleural Mesothelioma
Listing on: www.clinicaltrials.gov
Sponsor: Mayo Clinic
Location: Mayo Clinic Rochester, Minnesota
Principal Investigator: Shanda H Blackmon, MD, MPH Mayo Clinic
Contact: Karlyn Pierson, RN, MAN 507-538-1960 firstname.lastname@example.org
Bettie Lechtenberg, MBA 507-266-4819 email@example.com
Purpose: To see if neoadjuvant cryotherapy be safely performed in patients with malignant pleural mesothelioma and will it trigger a systemic and or local pro-inflammatory response in the induction of anti-tumor immunity.
Primary outcome Measure Number of patients with adverse events. Patients will be monitored for adverse events that may have resulted from a pleuroscopy procedure.
Estimated Enrollment 15
Study Start time July 2015
Estimated study completion date June 2017
Estimated Primary completion date June 2017
The study is still open and actively recruiting
Interventions: Patient will have their blood drawn prior to pleuroscopy for staging purposes. The biopsy will consist of pleural fluid and pleural biopsies that will have consist of 4-8 biopsies. During the procedure, there will be 2-3 applications of cryospray applied to the disease. (Usually the chest wall area). The minimum area is a 2×2 cm area which will continue for 15-20 seconds then thaw for 60 seconds followed by 1 to 2 times of cryotherapy before moving on to the next area. The freezing procedure will be video recorded and freezing locations and times will be recorded. Approximately 14 days following the staging pleuroscopy patients will undergo surgical treatment as per standard of care. Blood and pleural fluid and tissue collection will be performed as well.
Description: Patient that have been diagnosed or thought to have malignant pleural mesothelioma. Prior to surgery for treatment a pleuroscopy or video camera exam of the pleura will be conducted to establish diagnosis or extent of the disease. The purpose of this research is to gather information on the safety and effectiveness for cryotherapy in patients with malignant pleural mesothelioma.
Eligibility: Must be 18 years old male or female
- Patients provide informed consent
- Patients 18 years of age
- Patients competent for making informed decisions
- Patient will undergo pleuroscopy as part of their standard care for pre-operative clinical staging of malignant pleural mesothelioma.
- Pregnancy test is required to be negative
- Patient is mentally capable of understanding process of study
- Patient that have an INR 1.5 or greater
- If patient is on anticoagulants such as heparin, warfarin, and other types of anticoagulation have not been held for the standard time
- Vital signs will be stable heart rate greater than 120 unless deemed stable with these values by the surgical or interventional pulmonary attending physician. Also, systolic blood pressure will also not be less than 90 mmHG unless deemed stable
- Hypoxia with oxygen saturation less than 88% or a PA02 less than 60 measured from arterial blood gas.
- Participating in another study involving the investigational drugs or investigational medical devices
- If there is limited access to the pleural space or absence when performing medical pleuroscopy
- Inability to read and understand the necessary study documents
With any clinical trial, all participation is voluntary. Before enrollment a detailed consent form will be reviewed with the participant and signed. The participant can withdraw from a clinical trial at any point in time. Think about participating if able, the only way to progress to a cure for mesothelioma is through clinical trials.
Please do not hesitate to contact us with any questions.
Definition of Terms
Cryotherapy- is the therapeutic use of cold, is a technique that uses extremely cold liquid or an instrument to freeze and destroy abnormal cells. Used on common benign conditions such as warts and certain skin cancers.
Pleuroscopy- is the examination of the pleural cavity with an endoscope, through an incision on the thorax (chest).
Cryospray- the use of liquid nitrogen spray in cryosurgery
Cryosurgery- an operation using freezing temperature as an agent or an independent agent in an instrument to destroy tissue. It is the destruction of tissue using extreme cold: silver nitrate, and carbon dioxide are commonly used.