Intrapleural Cryotherapy for Malignant Pleural Mesothelioma

NCT02464904 | Terminated

• 1 other identifier: 14-008715
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Mesothelioma

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Adverse Events

  Participants will be monitored for any adverse events that may have resulted from the pleuroscopy procedure.

  1 month

• Mean Number of Tumor Infiltrating Immune Cells as Measured by Immunohistochemistry on Participant Tissue Samples

  14 days

Study Arms (2)

Cryotherapy

EXPERIMENTAL

Cryospray and biopsies

Procedure: Cryotherapy

Control

OTHER

Biopsies

Other: Control

Interventions

Cryotherapy PROCEDURE

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.

Cryotherapy

Control OTHER

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

Control

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• CSA Medical, Inc.: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Mesothelioma

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Shanda H Blackmon, MD, MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: June 8, 2015
• Study Start: July 1, 2015
• Primary Completion: February 26, 2021
• Study Completion: February 26, 2021
• Last Updated: February 9, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)