Feasibility and Clinically Application of Magnetic Resonance Fingerprinting

Glioma Clinical Trial

Official title:

Feasibility and Clinically Application of Magnetic Resonance Fingerprinting

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02387840
• Other study ID #: CASE7314
• Secondary ID: NCI-2015-00301
• Status: Terminated
• Phase: N/A
• Start date: March 2015
• Est. completion date: July 31, 2019

Study information

• Verified date: December 2020
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Tumor
• Glioma
• Neurofibroma
• Neurofibromatoses
• Neurofibromatosis 1
• Neurofibromatosis Type 1

Intervention

Device:
• Magnetic Resonance Imaging
Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.
• 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).

Locations

Country	Name	City	State
United States	Rainbow Babies and Children's Hospital	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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