Cleveland, Ohio 44106


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT02387840


Primary Contact:

Principal Investigator
Deborah R Gold, MD
Case Comprehensive Cancer Center

Deborah R Gold, MD
Phone: 216-844-3691
Email: deborah.gold@uhhospitals.org


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States

Deborah R Gold, MD
Phone: 216-844-3691
Email: deborah.gold@uhhospitals.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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