Feasibility and Clinically Application of Magnetic Resonance Fingerprinting

Case Comprehensive Cancer Center (Case CCC)

Status: Terminated

Conditions: Neurofibromatosis Type 1; Glioma; Brain Tumor

Treatments: Device: Magnetic Resonance Fingerprinting; Device: Magnetic Resonance Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02387840

NCI-2015-00301 (Registry Identifier)

CASE7314

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: Under 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 6 patient groups

NF1-associated Optic Pathway Glioma (OPG)

Experimental group

Description:

Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting

Treatment:

Device: Magnetic Resonance Imaging

Device: Magnetic Resonance Fingerprinting

NF1 without brain tumor

Experimental group

Description:

Patients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting

Treatment:

Device: Magnetic Resonance Imaging

Device: Magnetic Resonance Fingerprinting

Without NF1 and with brain tumor exposed to therapy

Experimental group

Description:

Patients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting

Treatment:

Device: Magnetic Resonance Imaging

Device: Magnetic Resonance Fingerprinting

Without NF1 and with untreated low grade brain tumors

Experimental group

Description:

Patients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting

Treatment:

Device: Magnetic Resonance Imaging

Device: Magnetic Resonance Fingerprinting

Without NF1 and without brain tumors

Experimental group

Description:

Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting

Treatment:

Device: Magnetic Resonance Imaging

Device: Magnetic Resonance Fingerprinting

Brain tumors of assorted pathology

Experimental group

Description:

Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting

Treatment:

Device: Magnetic Resonance Imaging

Device: Magnetic Resonance Fingerprinting