An interventional study of Magnetic Resonance Imaging and Magnetic Resonance Fingerprinting in Neurofibromatosis Type 1, Brain Tumor and Glioma, sponsored by Case Comprehensive Cancer Center. Terminated at 1 site in United States. Open to participants aged Up to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-12.
Sponsored by Case Comprehensive Cancer Center · Not applicable, Interventional, and Diagnostic
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.
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.
186 studies on the registry are indexed under Neurofibromatoses; 24 are open to participants now.
This study's enrollment of 35 is above the median of 26 across 120 interventional studies indexed under Neurofibromatoses.
Browse Neurofibromatoses studies →Case Comprehensive Cancer Center is the lead sponsor of 484 studies on the registry; 59 are open to participants now.
Of its 74 completed or terminated interventional studies of FDA-regulated products, 45 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
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
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
Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.
Also known as: MRI
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
Average Duration of MRF Sequence - Feasibility
The duration of MRF sequence in minutes will be recorded as a measure of feasibility
Time frame: Up to 1 year
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
Time frame: Up to 1 year
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.
Time frame: Up to 1 year
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.
Time frame: Up to 1 year
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
Time frame: Up to 1 year
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
Time frame: Up to 1 year
| Milestone | 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 |
|---|---|---|---|---|---|---|
| Started | 4 | 6 | 6 | 8 | 4 | 6 |
| Completed | 4 | 6 | 6 | 8 | 4 | 5 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 0 | 1 |
The duration of MRF sequence in minutes will be recorded as a measure of feasibility
| minutes | 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 |
|---|---|---|---|---|---|---|
| Average Duration of MRF Sequence - Feasibility | 11 ± 0 | 11 ± 0 | 11 ± 0 | 11 ± 0 | 11 ± 0 | 11 ± 0 |
Number of patients which have evaluable scans at both T1 and T2
| Participants | 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 |
|---|---|---|---|---|---|---|
| Number of Patients With Evaluable T1 and T2 Relaxation Times on MRF Scans | 4 | 6 | 6 | 8 | 4 | 6 |
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.
| milliseconds (ms) | Arms 1, 3, and 4 - Low Grade Gliomas | Arms 1, 3, and 4 - Normal Appearing White Matter |
|---|---|---|
| T1 | 1355 ± 187 | 916 ± 78 |
| T2 | 56 ± 19 | 38 ± 8 |
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.
| milliseconds (ms) | Arm 6 - High Grade Gliomas | Arm 6 - Normal Appearing White Matter |
|---|---|---|
| T1 | 1863 ± 70 | 979 ± 156 |
| T2 | 91 ± 13 | 45 ± 7 |
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
| milliseconds (ms) | Arms 1 & 4 - Untreated LGG | Arms 1 & 3 - Treated LGGs |
|---|---|---|
| T1 | 1410 ± 180 | 1265 ± 181 |
| T2 | 57 ± 15 | 47 ± 15 |
Descriptive statistics will be used to identify the T1 and T2 relaxation times for tumors of different types on pre-operative MRF scan
Results for this outcome have not been posted.
Collected over Up to 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NF1-associated Optic Pathway Glioma (OPG) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| NF1 Without Brain Tumor | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Without NF1 and With Brain Tumor Exposed to Therapy | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Without NF1 and With Untreated Low Grade Brain Tumors | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) |
| Without NF1 and Without Brain Tumors | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Brain Tumors of Assorted Pathology | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) |
Participants enrolled in study
| Age, Continuous(Years) | 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 | Total |
|---|---|---|---|---|---|---|---|
| Median | 4.5 (2 to 22) | 17.5 (3 to 24) | 14 (10 to 21) | 15 (8 to 22) | 12.5 (0 to 20) | 14 (1 to 34) | 15 (0 to 34) |
| Sex: Female, Male(Participants) | 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 | Total |
|---|---|---|---|---|---|---|---|
| Female | 2 | 3 | 4 | 6 | 3 | 0 | 18 |
| Male | 2 | 3 | 2 | 2 | 1 | 6 | 16 |
| Ethnicity (NIH/OMB)(Participants) | 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 | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 6 | 6 | 8 | 4 | 6 | 34 |
| Race (NIH/OMB)(Participants) | 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 | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 6 | 6 | 8 | 4 | 6 | 34 |
| Region of Enrollment(participants) | 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 | Total |
|---|---|---|---|---|---|---|---|
| United States | 4 | 6 | 6 | 8 | 4 | 6 | 34 |
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