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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01800032

Enrollment

Registered

2013-02-27

Start date

2013-01-16

Completion date

2019-12-05

Last updated

2021-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurofibromatosis-1, Optic Glioma, Plexiform Neurofibroma

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Plexiform Neurofibroma Cohort: Difference in FDG-avidity between progressive and non-progressive lesions	12 months	Ratios of SUVmax values within a group of patients who all have progressive disease
Optic Glioma Patients: Compare FDG-avidity between patients with progressive and non-progressive disease	12 months	—

Secondary

Measure	Time frame	Description
Report descriptive statistics for FDG-PET-MRI results	0, 12 months	SUV max, tumor/brain uptake ratio, tumor/muscle uptake ratio
Explore impact of FDG-PET-MRI surveillance on patient and family caregiver uncertainty and psychological distress	0, 12 months	—

Countries

United States

Outcome results