Using cryotherapy to treat neurofibromas in patients with Neurofibromatosis Type 1

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of percutaneous cryotherapy as a treatment for plexiform and unresectable neurofibromas in patients with Neurofibromatosis Type 1 (NF1). The procedure involves using fine needles to apply extreme cold to the tumors, potentially reducing pain and discomfort without the need for invasive surgery. Previous unpublished results from the Léon Bérard Center suggest that cryotherapy may offer a promising alternative to traditional surgical methods. The study aims to gather more data on this approach and its outcomes for patients suffering from NF1-related neurofibromas.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Centre Leon Berard
  Lyon, France Recruiting

Study contacts

• Study coordinator: Patrick COMBEMALE, MD
• Email: patrick.combemale@lyon.unicancer.fr
• Phone: +33478785996

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Testing PAS-004 for adults with Neurofibromatosis Type 1 and plexiform neurofibromas

  This study is testing a new medication called PAS-004 to see if it is safe and helps adults with Neurofibromatosis Type 1 and painful plexiform neurofibromas.

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• Imlygic (T-VEC) injections for cutaneous neurofibromas in adults with NF1

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• TQ-B3234 capsules for adults with symptomatic, inoperable NF1 plexiform neurofibromas

  This study will see if oral TQ-B3234 capsules can shrink or reduce symptoms from inoperable plexiform neurofibromas in adults with neurofibromatosis type 1 by Week 24 compared with placebo.

  Recruiting at 3 sites Phase 3 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Hefei, Anhui and 28 other locations · NCT07407803

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.