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Feasibility and Clinically Application of Magnetic Resonance Fingerprinting

Primary Purpose

Neurofibromatosis Type 1, Brain Tumor, Glioma

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Magnetic Resonance Imaging

Magnetic Resonance Fingerprinting

About this trial

This is an interventional diagnostic trial for Neurofibromatosis Type 1 focused on measuring Brain, Cancer, Neurofibromatosis type 1, NF1, Magnetic resonance fingerprinting, MRF

Eligibility Criteria

undefined - 35 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Rainbow Babies and Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

NF1-associated Optic Pathway Glioma (OPG)

NF1 without brain tumor

Without NF1 and with brain tumor exposed to therapy

Without NF1 and with untreated low grade brain tumors

Without NF1 and without brain tumors

Brain tumors of assorted pathology

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Average Duration of MRF Sequence - Feasibility

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

Number of patients which have evaluable scans at both T1 and T2

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.

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.

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

Full Information

NCT ID

NCT02387840

First Posted

February 27, 2015

Last Updated

December 18, 2020

Sponsor

Case Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT02387840

Brief Title

Feasibility and Clinically Application of Magnetic Resonance Fingerprinting

Official Title

Feasibility and Clinically Application of Magnetic Resonance Fingerprinting

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Terminated

Why Stopped

technician left institution

Study Start Date

March 2015 (undefined)

Primary Completion Date

July 31, 2019 (Actual)

Study Completion Date

July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neurofibromatosis Type 1, Brain Tumor, Glioma

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NF1-associated Optic Pathway Glioma (OPG)

Arm Type

Experimental

Arm Description

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

Arm Title

NF1 without brain tumor

Arm Type

Experimental

Arm Description

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

Arm Title

Without NF1 and with brain tumor exposed to therapy

Arm Type

Experimental

Arm Description

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

Arm Title

Without NF1 and with untreated low grade brain tumors

Arm Type

Experimental

Arm Description

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

Arm Title

Without NF1 and without brain tumors

Arm Type

Experimental

Arm Description

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

Arm Title

Brain tumors of assorted pathology

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Magnetic Resonance Imaging

Other Intervention Name(s)

MRI

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Magnetic Resonance Fingerprinting

Other Intervention Name(s)

MRF

Intervention Description

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).

Primary Outcome Measure Information:

Title

Average Duration of MRF Sequence - Feasibility

Description

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

Time Frame

Up to 1 year

Secondary Outcome Measure Information:

Title

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

Description

Number of patients which have evaluable scans at both T1 and T2

Time Frame

Up to 1 year

Title

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

Description

Time Frame

Up to 1 year

Title

Combination of Relaxometry MRI Scans Between High Grade Gliomas and Healthy Brain Tissue

Description

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.

Time Frame

Up to 1 year

Title

Comparison of Scans of Treated and Untreated Low Grade Gliomas (LGG)

Description

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

Time Frame

Up to 1 year

Other Pre-specified Outcome Measures:

Title

Comparison of Relaxometry Values Between Tumors of Varying Pathology

Description

Descriptive statistics will be used to identify the T1 and T2 relaxation times for tumors of different types on pre-operative MRF scan

Time Frame

Up to 1 year

10. Eligibility

Sex

All

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deborah R Gold, MD

Organizational Affiliation

Case Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rainbow Babies and Children's Hospital

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

12. IPD Sharing Statement

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Feasibility and Clinically Application of Magnetic Resonance Fingerprinting

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