The diagnosis of malignant peripheral nerve sheath tumours in patients with neurofibromatosis 1 MedDRA version: 12 Level: LLT Classification code 10029268 Term: Neurofibromatosis 1 associated malignant peripheral nerve sheath tumour
Conditions
Interventions
Product Name: [11C]-methionine
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: 2-amino-4-(methyl[11C]sulfanyl)butanoic acid
CAS Number: 63-68-3
Current Sponsor code: [11C]-L-methionine
Sponsors
Guys' and St. Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients over 16 years to 80 years fulfilling diagnostic criteria for NF1 /mosaic NF1 who have symptomatic plexiform or subcutaneous neurofibromas - persistent pain, rapid increase in size, change in texture, new or unexplained neurological deficit. Note: in mosaic NF1 clinical signs of NF1 restricted to one area of the body as the genetic change occurs after fertilisation. In generalised NF1 the genetic change occurs before fertilisation. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any prior treatment for the plexiform neurofibroma with chemotherapy or radiotherapy 2. History of recent significant cardiac arrhythmia 3. Concurrent congestive heart failure or prior history of class III / IV cardiac disease 4. Any other condition which in the Investigator’s opinion would not make the patient a good can candidate for the clinical trial 5. Patients who are pregnant will be excluded. If there is any doubt about pregnancy a pregnancy test will be taken. 6. Patients who are breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) To evaluate whether [11C]-methionine is more sensitive and specific than FDG PET CT in evaluating malignant transformation of plexiform neurofibromas in NF1 patients.;Secondary Objective: 1) To compare the semi-quantitative uptake of methionine with genetic analysis of the NF1- MPNST 2) To assess the safety of [11C]-methionine in patients with NF1 who are at risk of malignant transformation of plexiform neurofibromas to MPNST.;Primary end point(s): 1) Determine whether MET PET CT is more sensitive and specific than FDG PET CT in diagnosing NF1 associated MPNST. We will determine whether MET PET CT can predict grade and prognosis of NF1-associated MPNST 2) To improve identification of NF1 patients at risk for development of NF1-MPNSTs and to predict response to therapy 3) Determining whether an adverse event is related to [11C]-methionine and grading AE severity according to NCI CTCAE version 3.0. | — |
Countries
United Kingdom
Outcome results
None listed