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New treatment option for Neurofibroma
Official title Evaluation of Percutaneous Cryotherapy in the Treatment of Plexiform Neurofibromas and Unresectable Neurofibromas in Neurofibromatosis Type 1
ClinicalTrials.gov ID: NCT05199376
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Neutrophils \> 1 G/l in the 14 days prior to inclusion;
- Adequate coagulation test with normals values (as judged by the investigator);
You likely can't join if
- 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...
- 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...
- 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;
See the full eligibility 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;
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lyon, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lyon, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.