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)

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina-Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

UNC Hospitals

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Plexiform Neurofibroma
NF1 associated plexiform neurofibroma
Optic Glioma
NF1 associated optic glioma

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Timothy Gershon, MD, PhD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 16, 2013

Primary Completion (ACTUAL)

December 5, 2018

Study Completion (ACTUAL)

December 5, 2019

Study Registration Dates

First Submitted

February 25, 2013

First Submitted That Met QC Criteria

February 25, 2013

First Posted (ESTIMATE)

February 27, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 12, 2021

Last Update Submitted That Met QC Criteria

May 11, 2021

Last Verified

May 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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