Feasibility and Clinically Application of Magnetic Resonance Fingerprinting

Not Applicable

Terminated

Conditions: Brain Tumor
Glioma
Neurofibromatosis Type 1

Interventions: Device: Magnetic Resonance Imaging
Device: Magnetic Resonance Fingerprinting

Registration Number: NCT02387840

Lead Sponsor: Case Comprehensive Cancer Center

Brief 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 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 35

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NF1-associated Optic Pathway Glioma (OPG)	Magnetic Resonance Imaging	Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting
NF1 without brain tumor	Magnetic Resonance Imaging	Patients 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	Magnetic Resonance Imaging	Patients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting
NF1 without brain tumor	Magnetic Resonance Fingerprinting	Patients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting
Without NF1 and with untreated low grade brain tumors	Magnetic Resonance Fingerprinting	Patients 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	Magnetic Resonance Imaging	Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting
Without NF1 and with untreated low grade brain tumors	Magnetic Resonance Imaging	Patients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting
Brain tumors of assorted pathology	Magnetic Resonance Imaging	Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting
NF1-associated Optic Pathway Glioma (OPG)	Magnetic Resonance Fingerprinting	Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting
Without NF1 and with brain tumor exposed to therapy	Magnetic Resonance Fingerprinting	Patients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting
Without NF1 and without brain tumors	Magnetic Resonance Fingerprinting	Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting
Brain tumors of assorted pathology	Magnetic Resonance Fingerprinting	Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting

Primary Outcome Measures

Name	Time	Method
Average Duration of MRF Sequence - Feasibility	Up to 1 year	The duration of MRF sequence in minutes will be recorded as a measure of feasibility

Secondary Outcome Measures

Name	Time	Method
Comparison of Relaxometry MRI Scans Between Low Grade Gliomas and Healthy Brain Tissue	Up to 1 year	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.
Comparison of Scans of Treated and Untreated Low Grade Gliomas (LGG)	Up to 1 year	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
Combination of Relaxometry MRI Scans Between High Grade Gliomas and Healthy Brain Tissue	Up to 1 year	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.
Number of Patients With Evaluable T1 and T2 Relaxation Times on MRF Scans	Up to 1 year	Number of patients which have evaluable scans at both T1 and T2