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Feasibility and Clinically Application of Magnetic Resonance Fingerprinting

This study is currently recruiting participants.
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Verified January 2017 by Case Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02387840
First received: February 27, 2015
Last updated: January 5, 2017
Last verified: January 2017
  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.

Condition Intervention
Neurofibromatosis Type 1 Brain Tumor Glioma Device: Magnetic Resonance Imaging Device: Magnetic Resonance Fingerprinting

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Feasibility and Clinically Application of Magnetic Resonance Fingerprinting

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Number of patients with evaluable T1 and T2 relaxation times on MRF scans [ Time Frame: Up to 1 year ]
    Number of patients which have evaluable scans at both T1 and T2

  • Difference in relaxometry MRI scans between low grade gliomas and healthy brain tissue [ Time Frame: Up to 1 year ]
    Using Student's t-test, researchers will identify scans with significant difference in relaxometry between low grade gliomas and healthy brain tissue

  • Difference in scans of treated and untreated low grade gliomas [ Time Frame: Up to 1 year ]
    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


Other Outcome Measures:
  • Difference in relaxometry values between tumors of varying pathology [ Time Frame: Up to 1 year ]
    Descriptive statistics will be used to identify the T1 and T2 relaxation times for tumors of different types on pre-operative MRF scan


Estimated Enrollment: 80
Study Start Date: March 2015
Estimated Study Completion Date: June 2023
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: MRF

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.

  Eligibility

Ages Eligible for Study:   up to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02387840

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

Locations
United States, Ohio
Rainbow Babies and Children's Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Deborah R Gold, MD    216-844-3691    deborah.gold@uhhospitals.org   
Principal Investigator: Deborah R Gold, MD         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Deborah R Gold, MD Case Comprehensive Cancer Center
  More Information

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02387840     History of Changes
Other Study ID Numbers: CASE7314
NCI-2015-00301 ( Registry Identifier: CTRP )
Study First Received: February 27, 2015
Last Updated: January 5, 2017

Keywords provided by Case Comprehensive Cancer Center:
Brain
Cancer
Neurofibromatosis type 1
NF1
Magnetic resonance fingerprinting
MRF

Additional relevant MeSH terms:
Neurofibromatoses
Neurofibroma
Neurofibromatosis 1
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Peripheral Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on September 19, 2017