Feasibility and Clinically Application of Magnetic Resonance Fingerprinting

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 Overview

• Status: Terminated
• Conditions: Glioma; Brain Tumor; Neurofibromatosis Type 1
• Intervention / Treatment: Device: Magnetic Resonance Imaging; Device: Magnetic Resonance Fingerprinting

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Rainbow Babies and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Relaxometry Values Between Tumors of Varying Pathology	Descriptive statistics will be used to identify the T1 and T2 relaxation times for tumors of different types on pre-operative MRF scan	Up to 1 year

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Deborah R Gold, MD, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: February 27, 2015
• First Submitted That Met QC Criteria: March 12, 2015
• First Posted (Estimate): March 13, 2015

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: December 18, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Cancer; Brain; NF1; Neurofibromatosis type 1; Magnetic resonance fingerprinting; MRF
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Genetic Diseases, Inborn; Neuromuscular Diseases; Neurodegenerative Diseases; Neoplasms, Nerve Tissue; Peripheral Nervous System Diseases; Nervous System Neoplasms; Heredodegenerative Disorders, Nervous System; Neoplastic Syndromes, Hereditary; Nerve Sheath Neoplasms; Neurocutaneous Syndromes; Peripheral Nervous System Neoplasms; Neurofibromatoses; Neurofibromatosis 1; Neurofibroma
• Other Study ID Numbers: CASE7314; NCI-2015-00301 (Registry Identifier: CTRP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No