Clinical trial · Observational
PET/MRI in CNS and Extra-CNS Tumors of Patients With Neurofibromatosis-1 (NF1)
Pilot Study of [18F] Fluorodeoxyglucose Positron Emission Tomography- Magnetic Resonance Imaging (FDG-PET-MRI) in CNS and Extra-CNS Tumors of Patients With Neurofibromatosis-1 (NF1)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective pilot study is designed to provide preliminary data on the use of Fluorodeoxyglucose Positron Emission Tomography-Magnetic Resonance Imaging (FDG-PET-MRI) in patients with neurofibromatosis-1 (NF1) associated optic glioma and plexiform neurofibroma (PN). Subjects will undergo FDG-PET-MRI scans in place of standard of care imaging at 0 and 12 months, unless more frequent imaging is clinically indicated. Subjects and their family caregivers will also undergo serial interviews and complete questionnaires related to the psychosocial aspects of NF1.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neurofibromatosis-1 | — | UNRESOLVED | — |
| Optic Glioma | Optic Nerve Glioma | PROBABILISTIC | 0.70 |
| Plexiform Neurofibroma | Plexiform Neurofibroma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Plexiform Neurofibroma
- description
- NF1 associated plexiform neurofibroma
- label
- Optic Glioma
- description
- NF1 associated optic glioma
Primary outcomes (2)
- measure
- Plexiform Neurofibroma Cohort: Difference in FDG-avidity between progressive and non-progressive lesions
- timeFrame
- 12 months
- description
- Ratios of SUVmax values within a group of patients who all have progressive disease
- measure
- Optic Glioma Patients: Compare FDG-avidity between patients with progressive and non-progressive disease
- timeFrame
- 12 months
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with neurofibromatosis-1 with either optic glioma, due for imaging scan, or plexiform neurofibroma, due for imaging secondary to clinical signs or symptoms of progressive disease * ≥ 6 years of age * English-speaking * If female of child-bearing potential, negative urine pregnancy test performed within 7 days prior to each FDG-PET-MRI * Study-specific informed consent or assent obtained and signed Exclusion Criteria: * Unable to undergo FDG-PET-MRI without sedation * Currently undergoing chemotherapy for progressing optic glioma * Pregnant or lactating female * Poorly controlled diabetes mellitus * Presence of pacemaker, intracranial aneurysm clip, cochlear implant, metal halo device, epicardial pacemaker leads, or any other device that makes MRI unsafe * Serum creatinine \> 1.8 mg/dL OR GFR \< 30 mL/min * Unable to lie flat for \> 1 hour * Body Mass Index (BMI) \> 35
References
Publications (0)
Data not yet available