Feasibility and Clinically Application of Magnetic Resonance Fingerprinting

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility and Clinically Application of Magnetic Resonance Fingerprinting

Conditions
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Neurofibromatosis Type 1, Brain Tumor, Glioma

Intervention / Treatment
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* Device: Magnetic Resonance Imaging
* Device: Magnetic Resonance Fingerprinting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NF1-associated Optic Pathway Glioma (OPG)<br>Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting | Device: Magnetic Resonance Imaging<br>* Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.<br>* Other names: MRI;Device: Magnetic Resonance Fingerprinting<br>* 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).<br>* Other names: MRF;|
| Experimental: NF1 without brain tumor<br>Patients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting | Device: Magnetic Resonance Imaging<br>* Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.<br>* Other names: MRI;Device: Magnetic Resonance Fingerprinting<br>* 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).<br>* Other names: MRF;|
| Experimental: Without NF1 and with brain tumor exposed to therapy<br>Patients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting | Device: Magnetic Resonance Imaging<br>* Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.<br>* Other names: MRI;Device: Magnetic Resonance Fingerprinting<br>* 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).<br>* Other names: MRF;|
| Experimental: Without NF1 and with untreated low grade brain tumors<br>Patients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting | Device: Magnetic Resonance Imaging<br>* Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.<br>* Other names: MRI;Device: Magnetic Resonance Fingerprinting<br>* 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).<br>* Other names: MRF;|
| Experimental: Without NF1 and without brain tumors<br>Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting | Device: Magnetic Resonance Imaging<br>* Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.<br>* Other names: MRI;Device: Magnetic Resonance Fingerprinting<br>* 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).<br>* Other names: MRF;|
| Experimental: Brain tumors of assorted pathology<br>Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting | Device: Magnetic Resonance Imaging<br>* Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.<br>* Other names: MRI;Device: Magnetic Resonance Fingerprinting<br>* 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).<br>* Other names: MRF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Duration of MRF Sequence - Feasibility | The duration of MRF sequence in minutes will be recorded as a measure of feasibility | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 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 | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain, Cancer, Neurofibromatosis type 1, NF1, Magnetic resonance fingerprinting, MRF