Neurofibromatosis Type 1NCT02387840
Feasibility and Clinically Application of Magnetic Resonance Fingerprinting
A study testing Magnetic Resonance Imaging and Magnetic Resonance Fingerprinting in people with Neurofibromatosis Type 1 and Brain Tumor, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study will look at the feasibility of using magnetic resonance fingerprinting (MRF) in children, adolescents and young adults (AYA) with and without brain tumors. This study will also look at subjects with and without neurofibromatosis type 1(NF1), a genetic disorder that affects the growth of nervous system… Read more about this study
- Who is it for?
- Ages Up to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurofibromatosis Type 1, Brain Tumor, Glioma
- What is being tested?
- Magnetic Resonance Imaging and Magnetic Resonance Fingerprinting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subjects undergoing MRI evaluation of the brain
- NF1 status will be determined by clinical exam or genetic testing
- NF1-associated Optic Pathway Glioma (OPG) will be defined as radiographic evidence of glioma along the optic nerve, chiasm, tract or radiation in a child with NF1
- Untreated low grade gliomas will be imaging-defined gliomas that have not yet been exposed to radiation or systemic chemotherapy. Those exposed to therapy will have had radiation and/or systemic chemotherapy more than 1 month prior to scans
Who cannot join
- History of mental retardation unrelated to brain tumor
- Presence of a genetic disorder other than NF1 that effects cognition or is associated with MR imaging abnormalities (e.g. tuberous sclerosis)
- History of cerebrovascular accident (stroke)
- Birth weight below five pounds, premature birth prior to 36 weeks of gestation, or ischemic episode at birth
- Major psychiatric diagnosis prior to neuro-oncological diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
About this study
This study will look at the feasibility of using magnetic resonance fingerprinting (MRF) in children, adolescents and young adults (AYA) with and without brain tumors. This study will also look at subjects with and without neurofibromatosis type 1(NF1), a genetic disorder that affects the growth of nervous system cells. Further, it will explore potential ways of using of MRF signal measurements in children, adolescents, and young adults with brain tumors, including tissue characterization, looking at whether the treatment was effective, and finding metastasized tumors of unknown origin (occult tumors). To explore the feasibility and potential applications of MRF, this study will recruit up to 80 subjects but will stop once 10 subjects have usable data in each of six groups.
Read the detailed description
Specific Aim 1: Demonstrate the feasibility of magnetic resonance fingerprinting (MRF) in children, adolescents and young adults (AYA) with and without brain tumors.
Specific Aim 2: Characterize the MRF signature of low-grade gliomas
Specific Aim 3: Determine whether MRF can identify occult tumor in subjects with low-grade glioma.
Specific Aim 4: Determine whether MRF can identify treatment effects in low-grade gliomas.
Specific Aim 5: Explore whether common brain tumors can be differentiated by comparing pre-operative MRF signature with pathologic diagnosis.
Outline: This study will examine the feasibility of MRF in children and AYA and determine whether quantitative measures of T1 and T2 relaxation times can be derived in subjects <35 years of age. Approximately 80 subjects will be evaluated and include subgroups where MRF may be of particular utility, including children and AYA subjects with brain tumors and subjects with neurofibromatosis type 1 (NF1). Additional aims will investigate the utility of MRF in these groups.
- Conditions
- Neurofibromatosis Type 1, Brain Tumor, Glioma
- Being tested
- Magnetic Resonance Imaging, Magnetic Resonance Fingerprinting
- Keywords
- Brain, Cancer, Neurofibromatosis type 1, NF1, Magnetic resonance fingerprinting, MRF
- Medical subject headings
- Neurofibromatosis 1, Brain Neoplasms, Glioma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDevice
Also called MRI
Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.
Magnetic Resonance FingerprintingDevice
Also called MRF
Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).
| Study group | Role | What they receive |
|---|---|---|
| NF1-associated Optic Pathway Glioma (OPG) | Experimental | Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Receives: Device: Magnetic Resonance Imaging; Device: Magnetic Resonance Fingerprinting |
| NF1 without brain tumor | Experimental | Patients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Receives: Device: Magnetic Resonance Imaging; Device: Magnetic Resonance Fingerprinting |
| Without NF1 and with brain tumor exposed to therapy | Experimental | Patients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Receives: Device: Magnetic Resonance Imaging; Device: Magnetic Resonance Fingerprinting |
| Without NF1 and with untreated low grade brain tumors | Experimental | Patients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Receives: Device: Magnetic Resonance Imaging; Device: Magnetic Resonance Fingerprinting |
| Without NF1 and without brain tumors | Experimental | Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Receives: Device: Magnetic Resonance Imaging; Device: Magnetic Resonance Fingerprinting |
| Brain tumors of assorted pathology | Experimental | Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Receives: Device: Magnetic Resonance Imaging; Device: Magnetic Resonance Fingerprinting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Duration of MRF Sequence - Feasibility
The duration of MRF sequence in minutes will be recorded as a measure of feasibility
Measured: Up to 1 year
Secondary outcomes (4)
Number of Patients With Evaluable T1 and T2 Relaxation Times on MRF Scans
Number of patients which have evaluable scans at both T1 and T2
Measured: Up to 1 year
Comparison of Relaxometry MRI Scans Between Low Grade Gliomas and Healthy Brain Tissue
Using Wilcoxon rank sum test to compare continuous variables, researchers will identify scans with significant difference in relaxometry between low-grade (composite of arms 1,3,4) and versus healthy brain tissue.
Measured: Up to 1 year
Combination of Relaxometry MRI Scans Between High Grade Gliomas and Healthy Brain Tissue
Using Wilcoxon rank sum test to compare continuous variables, researchers will identify scans with significant difference in relaxometry between high-grade (arm 6) and versus healthy brain tissue.
Measured: Up to 1 year
Comparison of Scans of Treated and Untreated Low Grade Gliomas (LGG)
Using paired t-tests or non-parametric Wilcoxon signed rank tests, researchers will identify scans with significant differences in scans of treated and untreated tumors
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Why it stopped: technician left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neurofibromatosis Type 1Studies of the same condition, open and under way.
- More trials run by Case 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah R Gold, MD, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387840
- Sponsor's protocol ID
- CASE7314
- Other IDs
- NCI-2015-00301
- Status last verified
- Dec 2020
- First submitted
- 27 Feb 2015
- Last updated
- 12 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Clinically Application of Magnetic Resonance Fingerprinting
- ClinicalTrials.gov ID
- NCT02387840
- Acronym / sponsor ID
- CASE7314
- Conditions
- Neurofibromatosis Type 1, Brain Tumor, Glioma
- Keywords
- Brain, Cancer, Neurofibromatosis type 1, NF1, Magnetic resonance fingerprinting, MRF
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: technician left institution
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 13 Mar 2015 (estimated)
- Results
- Posted 12 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at the feasibility of using magnetic resonance fingerprinting (MRF) in children, adolescents and young adults (AYA) with and without brain tumors. This study will also look at subjects with and without neurofibromatosis type 1(NF1), a genetic disorder that affects the growth of nervous system cells. Further, it will explore potential ways of using of MRF signal measurements in children, adolescents, and young adults with brain tumors, including tissue characterization, looking at whether the treatment was effective, and finding metastasized tumors of unknown origin (occult tumors). To explore the feasibility and potential applications of MRF, this study will recruit up to 80 subjects but will stop once 10 subjects have usable data in each of six groups.
Detailed description
Specific Aim 1: Demonstrate the feasibility of magnetic resonance fingerprinting (MRF) in children, adolescents and young adults (AYA) with and without brain tumors.
Specific Aim 2: Characterize the MRF signature of low-grade gliomas
Specific Aim 3: Determine whether MRF can identify occult tumor in subjects with low-grade glioma.
Specific Aim 4: Determine whether MRF can identify treatment effects in low-grade gliomas.
Specific Aim 5: Explore whether common brain tumors can be differentiated by comparing pre-operative MRF signature with pathologic diagnosis.
Outline: This study will examine the feasibility of MRF in children and AYA and determine whether quantitative measures of T1 and T2 relaxation times can be derived in subjects <35 years of age. Approximately 80 subjects will be evaluated and include subgroups where MRF may be of particular utility, including children and AYA subjects with brain tumors and subjects with neurofibromatosis type 1 (NF1). Additional aims will investigate the utility of MRF in these groups.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| NF1-associated Optic Pathway Glioma (OPG) | Experimental | Device: Magnetic Resonance Imaging, Device: Magnetic Resonance FingerprintingPatients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting |
| NF1 without brain tumor | Experimental | Device: Magnetic Resonance Imaging, Device: Magnetic Resonance FingerprintingPatients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting |
| Without NF1 and with brain tumor exposed to therapy | Experimental | Device: Magnetic Resonance Imaging, Device: Magnetic Resonance FingerprintingPatients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting |
| Without NF1 and with untreated low grade brain tumors | Experimental | Device: Magnetic Resonance Imaging, Device: Magnetic Resonance FingerprintingPatients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting |
| Without NF1 and without brain tumors | Experimental | Device: Magnetic Resonance Imaging, Device: Magnetic Resonance FingerprintingPatients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting |
| Brain tumors of assorted pathology | Experimental | Device: Magnetic Resonance Imaging, Device: Magnetic Resonance FingerprintingPatients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting |
Who may qualify
- Ages
- Up to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Subjects undergoing MRI evaluation of the brain
- NF1 status will be determined by clinical exam or genetic testing
- NF1-associated Optic Pathway Glioma (OPG) will be defined as radiographic evidence of glioma along the optic nerve, chiasm, tract or radiation in a child with NF1
- Untreated low grade gliomas will be imaging-defined gliomas that have not yet been exposed to radiation or systemic chemotherapy. Those exposed to therapy will have had radiation and/or systemic chemotherapy more than 1 month prior to scans
Key exclusion criteria (5 listed)
- History of mental retardation unrelated to brain tumor
- Presence of a genetic disorder other than NF1 that effects cognition or is associated with MR imaging abnormalities (e.g. tuberous sclerosis)
- History of cerebrovascular accident (stroke)
- Birth weight below five pounds, premature birth prior to 36 weeks of gestation, or ischemic episode at birth
- Major psychiatric diagnosis prior to neuro-oncological diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingAlso: MRIPatients will have a scan of soft tissue using magnetic field and radio frequency pulses. | Device | Brain tumors of assorted pathology, NF1 without brain tumor, NF1-associated Optic Pathway Glioma (OPG), Without NF1 and with brain tumor exposed to therapy, Without NF1 and with untreated low grade brain tumors, Without NF1 and without brain tumors |
| Magnetic Resonance FingerprintingAlso: MRFMagnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2). | Device | Brain tumors of assorted pathology, NF1 without brain tumor, NF1-associated Optic Pathway Glioma (OPG), Without NF1 and with brain tumor exposed to therapy, Without NF1 and with untreated low grade brain tumors, Without NF1 and without brain tumors |
Primary outcome
Average Duration of MRF Sequence - Feasibility
Time frame: Up to 1 year
The duration of MRF sequence in minutes will be recorded as a measure of feasibility
4 secondary outcomes
Number of Patients With Evaluable T1 and T2 Relaxation Times on MRF Scans
Time frame: Up to 1 year
Comparison of Relaxometry MRI Scans Between Low Grade Gliomas and Healthy Brain Tissue
Time frame: Up to 1 year
Combination of Relaxometry MRI Scans Between High Grade Gliomas and Healthy Brain Tissue
Time frame: Up to 1 year
Comparison of Scans of Treated and Untreated Low Grade Gliomas (LGG)
Time frame: Up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Deborah R Gold, MD principal investigator
Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging and Magnetic Resonance Fingerprinting in people with Neurofibromatosis Type 1 and Brain Tumor, run by Case 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 12 Jan 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?
Yes. Results are posted in the registry (first posted 12 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Duration of MRF Sequence - Feasibility (time frame: Up to 1 year). 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 Jan 2021.