Neurofibromatosis-1NCT01800032
PET/MRI in CNS and Extra-CNS Tumors of Patients With Neurofibromatosis-1 (NF1)
An observational study of Neurofibromatosis-1 and Optic Glioma, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Neurofibromatosis-1, Optic Glioma, Plexiform Neurofibroma
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2013to 5 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: UNC Hospitals
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: 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.
- Conditions
- Neurofibromatosis-1, Optic Glioma, Plexiform Neurofibroma
- Medical subject headings
- Optic Nerve Glioma, Neurofibroma, Plexiform
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Plexiform Neurofibroma | NF1 associated plexiform neurofibroma | |
| Optic Glioma | NF1 associated optic glioma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plexiform Neurofibroma Cohort: Difference in FDG-avidity between progressive and non-progressive lesions
Ratios of SUVmax values within a group of patients who all have progressive disease
Measured: 12 months
Optic Glioma Patients: Compare FDG-avidity between patients with progressive and non-progressive disease
Measured: 12 months
Secondary outcomes (2)
Report descriptive statistics for FDG-PET-MRI results
SUV max, tumor/brain uptake ratio, tumor/muscle uptake ratio
Measured: 0, 12 months
Explore impact of FDG-PET-MRI surveillance on patient and family caregiver uncertainty and psychological distress
Measured: 0, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study start16 Jan 2013
- Primary completion5 Dec 2018
- Study completion5 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurofibromatosis-1Studies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy Gershon, MD, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800032
- Sponsor's protocol ID
- LCCC1222
- Status last verified
- May 2021
- First submitted
- 25 Feb 2013
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01800032
- Acronym / sponsor ID
- LCCC1222
- Conditions
- Neurofibromatosis-1, Optic Glioma, Plexiform Neurofibroma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 16 Jan 2013 (actual)
- Primary completion
- 5 Dec 2018 (actual)
- Study completion
- 5 Dec 2019 (actual)
- First posted
- 27 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plexiform Neurofibroma | – | –NF1 associated plexiform neurofibroma |
| Optic Glioma | – | –NF1 associated optic glioma |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- UNC Hospitals
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Optic Glioma Patients: Compare FDG-avidity between patients with progressive and non-progressive disease
Time frame: 12 months
2 secondary outcomes
Report descriptive statistics for FDG-PET-MRI results
Time frame: 0, 12 months
Explore impact of FDG-PET-MRI surveillance on patient and family caregiver uncertainty and psychological distress
Time frame: 0, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Gershon, MD, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurofibromatosis-1 and Optic Glioma, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plexiform Neurofibroma Cohort: Difference in FDG-avidity between progressive and non-progressive lesions (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021.