Skip to main content
Clinical Trials/NCT02387840
NCT02387840
Terminated
Not Applicable

Feasibility and Clinically Application of Magnetic Resonance Fingerprinting

Case Comprehensive Cancer Center1 site in 1 country35 target enrollmentMarch 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurofibromatosis Type 1
Sponsor
Case Comprehensive Cancer Center
Enrollment
35
Locations
1
Primary Endpoint
Average Duration of MRF Sequence - Feasibility
Status
Terminated
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
July 31, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Average Duration of MRF Sequence - Feasibility

Time Frame: Up to 1 year

The duration of MRF sequence in minutes will be recorded as a measure of feasibility

Secondary Outcomes

  • Comparison of Relaxometry MRI Scans Between Low Grade Gliomas and Healthy Brain Tissue(Up to 1 year)
  • Comparison of Scans of Treated and Untreated Low Grade Gliomas (LGG)(Up to 1 year)
  • Combination of Relaxometry MRI Scans Between High Grade Gliomas and Healthy Brain Tissue(Up to 1 year)
  • Number of Patients With Evaluable T1 and T2 Relaxation Times on MRF Scans(Up to 1 year)

Study Sites (1)

Loading locations...

Similar Trials