Actively Recruiting
Evaluation of Percutaneous Cryotherapy for Plexiform and Unresectable Neurofibromas in Neurofibromatosis Type 1
Led by Centre Leon Berard · Updated on 2024-02-09
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating percutaneous cryotherapy as a treatment for patients with neurofibromatosis type 1 (NF1), a genetic condition that causes neurogenic tumors called neurofibromas. These tumors can cause pain, functional problems, and cosmetic issues. Surgical treatment is often invasive and can lead to significant scarring. This study aims to confirm encouraging early results suggesting that cryotherapy may improve quality of life and reduce tumor size in patients with unresectable or difficult-to-treat neurofibromas. The study uses percutaneous cryotherapy, a cold thermoablation technique involving fine needles inserted into the tumor under imaging guidance. The treatment lasts about 30 minutes and involves two 10-minute freezing cycles separated by a warming phase, lowering the tumor temperature to lethal levels for cells. This procedure is studied in patients with painful or functionally impairing benign neurofibromas that cannot be removed surgically without severe scarring. Participants will be monitored for up to 24 months after the cryotherapy. Researchers will assess physical health-related quality of life, tumor response, pain, functional discomfort, safety, patient satisfaction, self-esteem, and the need for additional cryotherapy sessions. Evaluations will occur at multiple time points, including baseline and various months post-treatment. The study also measures operating room time during the procedure and collects data on quality of life using the Short Form-36 questionnaire.
CONDITIONS
Brief Title
Evaluation of Percutaneous Cryotherapy in the Treatment of Plexiform Neurofibromas and Unresectable Neurofibromas in Neurofibromatosis Type 1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of neurofibromatosis type 1 according to NIH criteria
- Presence of a benign neurofibromatous lesion that is painful and/or causes functional discomfort and is unresectable or would require unacceptable scarring
- Neutrophil count greater than 1 G/l within 14 days before inclusion
- Normal coagulation test results as judged by the investigator
- Signed and dated informed consent after being informed about all trial aspects
- Covered by medical insurance
You will not qualify if you...
- Receiving chemotherapy or targeted therapies during the study
- Contraindication to percutaneous cryotherapy, including need for ice formation near the spinal cord, brain, critical nerves, bowel, or bladder without protective measures
- Malignant neurofibroma or malignant peripheral nerve sheath tumor (MPNST)
- Neurofibroma in areas with risk of neurological damage
- History of cold urticaria with angioedema
- Cognitive impairment limiting use of numerical scales or quality of life questionnaires
- Inability to comply with follow-up
- Participation in another clinical trial that could affect primary endpoint evaluation
- Under legal guardianship or deprived of liberty
- Pregnant or breastfeeding women
- Contraindication to MRI
- Presence of dysplastic neurofibroma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session on Day 0
Participants receive percutaneous cryotherapy involving two 10-minute freezing cycles separated by a reheating phase to treat their neurofibromas.
1 treatment visit (in-person)
Duration - Up to 24 months after treatment
Participants are monitored for safety, tumor response, quality of life, pain, functional discomfort, and other outcomes for up to 24 months after cryotherapy.
Visits at Month 1, 3, 6, 9, 12, 18, and 24 post-treatment
Trial Site Locations
Total: 1 location
1
Centre Leon Berard
Lyon, France, 69373
Actively Recruiting
Research Team
P
Patrick COMBEMALE, MD
A
Amine BOUHAMAMA, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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