Cryoablation of Venous Vascular Malformations

Study Overview
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Brief Summary
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To now, two alternatives for the management of venous vascular malformations are recognized, appropriate to the location, size and patients: sclerosis and surgery. However, sclerosis is effective on symptoms in 80% of cases and excision removes the malformation completely or partially, but it is aggressive and recurrences are common.

Detailed Description
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In order to propose an additional alternative option, cryoablation has been recently tested with promising results. Therefore, the purpose of this study is to evaluate the safety and efficacy of cryotherapy on venous vascular malformations. Fourteen patients will be included after discussion in multidisciplinary meeting. Patients will be follow until 6 months to evaluate the safety and the 6 months efficacy on symptoms. A MRI will be perform at 6 months to evaluate the size of ablated zone following RECIST criteria.

Official Title
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Cryoablation of Venous Vascular Malformations Located in Soft Tissues

Conditions
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Venous Vascular Malformation

Intervention / Treatment
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* Device: Percutaneous Image-guided Cryoablation (FPRPR3508 IceRod® PLUS Needles)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient over 18 years, Initial radiological diagnosis of venous or glomovenous vascular malformation proved by Doppler ultrasound and MRI, Recurrence of symptoms after initial treatment, Symptomatic deformation :pain, tangible mass,functional discomfort Recurrence after treatment by surgery or sclerosis Cryotherapy considered technically feasible after discussion in multidisciplinary committee, Localization at distance from the skin and major neurovascular structures, Absence of contra-indication of anaesthesia, Signed informed consent, Coverage by French social security Exclusion Criteria: Localization of the lesion does not allow the implementation of cryotherapy in adequate conditions: ablation zone too close to the major anatomic structures (nerve), TP <50% TCA> 1.5 x control, anticoagulation Platelets <90000/mm3, Progressive infection Patient included in another clinical study, Unable to undergo medical tests for geographical, social or psychological, Adult under a legal guardianship or unable to consent, Pregnancy and breastfeeding.

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: only one treatment group<br>Patients presenting inoperable venous vascular malformations in soft tissues with indication of cryoablation. | Device: Percutaneous Image-guided Cryoablation (FPRPR3508 IceRod® PLUS Needles)<br>* Treatment consists of a percutaneous cryoablation performed under anesthesia and imaging control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of cryoablation by measuring the immediate complications using NCI-CTCAE toxicity scale. |  | 7 days after cryoablation | 
| To evaluate the safety of cryoablation by measuring the delayed complications using NCI-CTCAE toxicity scale. |  | 1 month after cryoablation | 
| To evaluate the safety of cryoablation by measuring the delayed complications using NCI-CTCAE toxicity scale. |  | 2 months after cryoablation | 
| To evaluate the safety of cryoablation by measuring the late complications using NCI-CTCAE toxicity scale. |  | 6 months after cryoablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All adverse events using NCI-CTCAE |  | 7 days, 1 month ,2 months + 6 months after cryoablation | 
| Clinical response (decrease of pain and/or functional discomfort) |  | 6 months after cryoablation | 
| Imaging response (RECIST 1.1) |  | 6 months after cryoablation | 
| Quality of life using QLQ-C30 |  | 2 months & 6 months after cryoablation | 
| Pain using visual analogue scale |  | 7 days, 1 month ,2 months & 6 months after cryoablation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cryoablation, Venous vascular malformation, MRI, safety, pain