Clinical trial NCT02387840: Feasibility and Clinically Application of Magnetic Resonance Fingerprinting
Official title: Feasibility and Clinically Application of Magnetic Resonance Fingerprinting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neurofibromatosis Type 1
Brain Tumor
Glioma
Keywords: Brain
Cancer
Neurofibromatosis type 1
NF1
Magnetic resonance fingerprinting
MRF
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2015-03-13
Enrollment: 35
Sex: ALL
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Average Duration of MRF Sequence - Feasibility
timeFrame: Up to 1 year
Secondary outcomes:
measure: Number of Patients With Evaluable T1 and T2 Relaxation Times on MRF Scans
timeFrame: Up to 1 year
measure: Comparison of Relaxometry MRI Scans Between Low Grade Gliomas and Healthy Brain Tissue
timeFrame: Up to 1 year
measure: Combination of Relaxometry MRI Scans Between High Grade Gliomas and Healthy Brain Tissue
timeFrame: Up to 1 year
measure: Comparison of Scans of Treated and Untreated Low Grade Gliomas (LGG)
timeFrame: Up to 1 year
Other outcomes:
measure: Comparison of Relaxometry Values Between Tumors of Varying Pathology
timeFrame: Up to 1 year
Locations:
city: Cleveland
country: United States
facility: Rainbow Babies and Children's Hospital
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Deborah R Gold, MD
role: PRINCIPAL_INVESTIGATOR
References: