Clinical trial · Interventional
Intrapleural Cryotherapy for Malignant Pleural Mesothelioma
Pilot Study Evaluating the Effects of Intrapleural Cryotherapy on Tumor Infiltrating Lymphocytes in Malignant Pleural Mesothelioma Using Cryospray Therapy
NCT02464904CI-TRIAL-00056424terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty enrolling patients due to enrollment criteria.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control | Other | — | UNRESOLVED |
| Cryotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cryotherapy
- description
- Cryospray and biopsies
- interventionNames
- Procedure: Cryotherapy
- type
- OTHER
- label
- Control
- description
- Biopsies
- interventionNames
- Other: Control
Primary outcomes (2)
- measure
- Number of Participants with Adverse Events
- timeFrame
- 1 month
- description
- Participants will be monitored for any adverse events that may have resulted from the pleuroscopy procedure.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.