Status:
RECRUITING
Evaluation of Percutaneous Cryotherapy in the Treatment of Plexiform Neurofibromas and Unresectable Neurofibromas in Neurofibromatosis Type 1
Lead Sponsor:
Centre Leon Berard
Conditions:
Neurofibroma
Neurofibroma, Plexiform
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Neurofibromatosis type 1 (NF1) is an autosomal dominant disease affecting chromosome 17. It is manifested by a neurogenic tumor proliferation that forms cutaneous, subcutaneous or deep neurofibromas. ...
Eligibility Criteria
Inclusion
- Age ≥18 years;
- Patient with neurofibromatosis type 1 according to NIH criteria ;
- Patient with a benign neurofibromatous lesion that is painful and/or generates functional discomfort and is unresectable or with unacceptable scarring ;
- Neutrophils \> 1 G/l in the 14 days prior to inclusion;
- Adequate coagulation test with normals values (as judged by the investigator);
- Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment
- Covered by a medical insurance;
Exclusion
- Patient treated with concomitant chemotherapy and/or targeted therapies ;
- Any contraindication to a percutaneous cryotherapy procedure, including the need for ice formation within 1 cm of the spinal cord, brain or other critical nerve structures, bowel or bladder (unless active or passive thermal protective maneuvers are performed);
- Patient with malignant neurofibroma or MPNST ; CT scan without abnormality and if tumor presents a max SUV T/F\>1.5 ratio, targeted biopsy is required to confirm benign or malignant histology.
- Patient with neurofibroma in areas at risk for neurological sequelae;
- Patient with cold urticaria with history of angioedema;
- Any cognitive impairment or condition that may limit the use of numerical scales and quality of life questionnaires;
- Patient for whom follow-up does not seem feasible even in the short term;
- Participation in another clinical trial that may interfere with the evaluation of the primary endpoint;
- Patient under tutorshio, curatorship or deprived of liberty;
- Pregnant or breast-feeding woman;
- Any contraindication to the performance of an MRI
- Patient with dysplastic neurofibroma
Key Trial Info
Start Date :
February 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 7 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05199376
Start Date
February 14 2022
End Date
February 7 2027
Last Update
February 9 2024
Active Locations (1)
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1
Centre Leon Berard
Lyon, France, 69373