Feasibility and Clinically Application of Magnetic Resonance Fingerprinting

NCT02387840 | Terminated Results DMC FDA Device

• 2 other identifiers: CASE7314NCI-2015-00301
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurofibromatosis Type 1; Brain Tumor; Glioma

Keywords

Brain; Cancer; Neurofibromatosis type 1; NF1; Magnetic resonance fingerprinting; MRF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Patients With Evaluable T1 and T2 Relaxation Times on MRF Scans

  Up to 1 year

• Comparison of Relaxometry MRI Scans Between Low Grade Gliomas and Healthy Brain Tissue

  Up to 1 year

• Combination of Relaxometry MRI Scans Between High 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

Other Outcomes (1)

• Comparison of Relaxometry Values Between Tumors of Varying Pathology

  Up to 1 year

Study Arms (6)

NF1-associated Optic Pathway Glioma (OPG)

EXPERIMENTAL

Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting

Device: Magnetic Resonance Imaging; Device: Magnetic Resonance Fingerprinting

NF1 without brain tumor

EXPERIMENTAL

Patients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting

Device: Magnetic Resonance Imaging; Device: Magnetic Resonance Fingerprinting

Without NF1 and with brain tumor exposed to therapy

EXPERIMENTAL

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; Device: Magnetic Resonance Fingerprinting

Without NF1 and with untreated low grade brain tumors

EXPERIMENTAL

Patients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting

Device: Magnetic Resonance Imaging; Device: Magnetic Resonance Fingerprinting

Without NF1 and without brain tumors

EXPERIMENTAL

Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting

Device: Magnetic Resonance Imaging; Device: Magnetic Resonance Fingerprinting

Brain tumors of assorted pathology

EXPERIMENTAL

Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting

Device: Magnetic Resonance Imaging; Device: Magnetic Resonance Fingerprinting

Interventions

Magnetic Resonance Imaging DEVICE

Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.

Also known as: MRI

Brain tumors of assorted pathology; NF1 without brain tumor; NF1-associated Optic Pathway Glioma (OPG); Without NF1 and with brain tumor exposed to therapy; Without NF1 and with untreated low grade brain tumors; Without NF1 and without brain tumors

Magnetic Resonance Fingerprinting DEVICE

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).

Also known as: MRF

Brain tumors of assorted pathology; NF1 without brain tumor; NF1-associated Optic Pathway Glioma (OPG); Without NF1 and with brain tumor exposed to therapy; Without NF1 and with untreated low grade brain tumors; Without NF1 and without brain tumors

Eligibility Criteria

• Age: Up to 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Neurofibromatosis 1; Brain Neoplasms; Glioma; Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neurofibromatoses; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Dr. Deborah Runkin Gold
• Organization: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

CTUReferral@UHhospitals.org

1-800-641-2422

Study Officials

• Deborah R Gold, MD

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2015
• First Posted: March 13, 2015
• Study Start: March 1, 2015
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: January 12, 2021
• Results First Posted: January 12, 2021

Record last verified: 2020-12

Locations

US (1)