Intrapleural Cryotherapy for Malignant Pleural Mesothelioma

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 14-008715
    NCT ID: NCT02464904
    Sponsor Protocol Number: 14-008715

About this study

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?

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Shanda Blackmon, M.D., M.P.H.

Open for enrollment

Contact information:

Thoracic Surgery Research Unit

(877) 526-9172

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20145580

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