NCT02387840

Feasibility and Clinically Application of Magnetic Resonance Fingerprinting

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Neurofibromatosis Type 1
• Brain Tumor
• Glioma

Interventions

Type	Name	Description
DEVICE	Magnetic Resonance Imaging	Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.
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).

Timeline

• Start date: 2015-03-01
• Primary completion: 2019-07-31
• Completion: 2019-07-31
• First posted: 2015-03-13
• Last updated: 2021-01-12
• Results posted: 2021-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study