Safety, Efficacy, and Side Effects Study of Interventional Cryotherapy in the Pleural Space(ICE PLS)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, efficacy, and side effects of the CryoSpray Ablation(TM) System (CSA(TM) System) to treat neoplastic lesions on the parietal pleural surface.

Detailed Description
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The proposed study is a pilot study consisting of an estimated 10 subjects with biopsy-proven metastatic cancer in the parietal pleural surface treated with CryoSpray at dye marked metastatic foci. Initial treatment dosimetry will be up to 3 cycles of 10-40 second sprays. If necessary, dosimetry changes may occur after 3 subjects are treated and observed. It is unknown if dosimetry will need to be increased to enhance effectiveness. The PI may increase dosimetry by 1 cycle after each subject is treated and observed as a conservative approach to efficacy determination. If disease exists bilaterally, only one side will be sprayed.

Official Title
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A Pilot Study of the Safety, Efficacy, and Side Effects of Interventional Cryotherapy for the Eradication of Disease in the Pleural Space (ICE PLS)

Conditions
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Cancer, Pleural Neoplasms

Intervention / Treatment
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* Device: CryoSpray Ablation (TM) System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age Deemed a candidate for cryotherapy based on physician physical or medical history review Deemed operable based on institutional criteria Able to sign informed consent Documented lung or other visceral cancer with pleural involvement. WBC > 4,000/mm3, platelets >100,000mm3 Physically well enough to undergo moderate sedation and pleuroscopy Female patients must be HCG negative There should be direct evidence of disease progression despite treatment in previously treated patients Exclusion Criteria: Pregnant or nursing Planning to sire a child while enrolled in the study Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines. Refusal or inability to give consent. Concurrent chemotherapy. Medical contraindication or potential problem that would preclude study participation Concurrent participation in other experimental studies Uncontrolled coagulopathy or bleeding diathesis Serious medical illness, including: Uncontrolled congestive heart failure Uncontrolled angina Myocardial infarction Cerebrovascular accident within 6 months prior to study entry

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CryoSpray Ablation (TM) System<br>subjects will receive cryotherapy using the CryoSpray Ablation (TM) System DOSE: up to 3 cycles of 10-40 second sprays | Device: CryoSpray Ablation (TM) System<br>* Subjects will be treated with spray cryotherapy using the CryoSpray Ablation (TM) System at Day 0 using up to 3 cycles of 10-40 second sprays as the studied dosimetry and will cover the affected area, including the tumor and the parietal pleural surface. If disease exists bilaterally, only one side will be sprayed. Subjects will be assessed 2-5 days from the initial treatment (Day 0) to check for mucosal sloughing, to reassess tumor burden and for additional CSA therapy as needed.<br>* Other names: Cryospray;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Reduce Tumor Burden in the Pleural Space, as Determined by Visual Inspection and Biopsy of the Treatment Sites 2-5 Days Post Treatment. Safety Endpoint Clinical and Radiographic Status at 30 Days Post CryoSpray Treatment and Adverse Events. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Determine if CryoSpray Causes a Pleurodesis Effect. To Determine if CryoSpray Affects Production of Malignant Effusion Within the Treated Pleural Cavity. To Determine if Pleural Cavity Treatment With CryoSpray is Dosimetry Dependent. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parietal pleura, Neoplasms, Pleural Surface, Pleural Neoplasms, Lung Cancer