Description:
The purpose of the research study is to test new methods that could improve diagnosis and
assessment of brain tumors. One of these methods is a new MR (magnetic resonance) imaging
technique called magnetic resonance fingerprinting (MRF), which allows for rapidly scanning
the patient and provides quantitative information on tumor tissue. The investigators will
compare the data gathered from MR Fingerprinting with other imaging tests, clinical
information, treatment details and biopsy results to evaluate the accuracy of this new
technique.
Title
- Brief Title: Multi-Parametric Quantitative MR Imaging in Evaluation of Brain Tumors
- Official Title: Multi-Parametric Quantitative MR Imaging in Evaluation of Brain Tumors
Clinical Trial IDs
- ORG STUDY ID:
CASE8316
- NCT ID:
NCT02956291
Conditions
Purpose
The purpose of the research study is to test new methods that could improve diagnosis and
assessment of brain tumors. One of these methods is a new MR (magnetic resonance) imaging
technique called magnetic resonance fingerprinting (MRF), which allows for rapidly scanning
the patient and provides quantitative information on tumor tissue. The investigators will
compare the data gathered from MR Fingerprinting with other imaging tests, clinical
information, treatment details and biopsy results to evaluate the accuracy of this new
technique.
Detailed Description
The primary objective of this study is to 1) evaluate the utility of quantitative MRI imaging
including 3D-MRF in differentiating among different brain tumors and differentiating
recurrent brain tumor (TR) from treatment effects
Secondary objectives include evaluating the correlation between quantitative MRI imaging with
histopathological characteristics and genetic markers in pre-therapy setting and with
treatment response and clinical outcomes in post treatment setting.
GROUP 1: All patients with newly diagnosed intra-axial brain neoplasms undergo volumetric MRI
study with contrast for surgical planning or clinical diagnosis. Diffusion, diffusion tensor
imaging and perfusion imaging are often performed as a part of standard clinical imaging. In
addition to these acquisitions, the research 3D-MRF acquisition through the entire tumor will
be acquired. The imaging parameters will be correlated individually and in combination with
biopsy/ resection outcomes.
GROUP 2: All patients with brain tumors who present at post therapy follow up with imaging
progression undergo serial imaging as a part of clinical care. The research 3D-MRF
acquisitions will be added to these clinical scans. All the quantitative parameters will be
evaluated individually and in combination to differentiate post treatment changes from tumor
recurrence.
Trial Arms
Name | Type | Description | Interventions |
---|
Newly Diagnosed Brain Tumors | Experimental | Participants with newly diagnosed brain tumors will undergo Magnetic Resonance Fingerprinting (MRF) scan along with their clinical scan, followed by standard of care surgery, radiation, and chemotherapy. Follow-up MRF scans will be performed to visualize recurrence. | |
Treated tumors with possible recurrence | Experimental | Participants with treated brain tumors with possible recurrence will undergo Magnetic Resonance Fingerprinting (MRF) scan along with their clinical scan, followed by standard of care surgery, radiation, and chemotherapy. Follow-up MRF scans will be added to the repeat MRI studies as determined appropriate by the referring physician/primary care team. | |
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of intra-axial brain tumor at initial diagnosis or patients with known
treated brain tumors on follow-up with concern for imaging progression
- Ability to understand and the willingness to sign a written informed consent document,
or, in cases where the patient may have cognitive impairment, consent by a legal
authorized representative or power of attorney
Exclusion Criteria:
- Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips.
- The presence of an implanted pacemaker or implanted defibrillator device.
- Patients with contraindications for MRI due to embedded foreign metallic objects.
Bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary
risk to the patient.
- Pregnancy. Regular clinical practice already excludes pregnant patients from
gadolinium contrast.
- Implanted medical device not described above that is not MRI-compatible.
- Known history of severe claustrophobia.
- Prisoners and members of other vulnerable populations will be excluded from this
study. The subject selection population will not regularly include prisoners and other
vulnerable population members as these populations will not provide any additional
unique information to or uniquely benefit from the study. Non-English speaking
population will be excluded from the study due to lack of sufficient resources to pay
for translator and interpreter services.
- Minors will be excluded.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | T1 relaxometry value of Region of Interest (ROI) in MRF scan for each tumor type |
Time Frame: | At end of scan (45 minuets after beginning study) |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Number of patients whose clinical diagnosis and quantitative imaging diagnosis match |
Time Frame: | At end of scan (45 minuets after beginning study) |
Safety Issue: | |
Description: | |
Measure: | In treated tumors, difference in T1 relaxation times between baseline and 6 months post surgery |
Time Frame: | 6 months post-operative |
Safety Issue: | |
Description: | |
Measure: | In treated tumors, difference in T2 relaxation times between baseline and 6 months post surgery |
Time Frame: | 6 months post-operative |
Safety Issue: | |
Description: | |
Measure: | In treated tumors, difference in T1 and T2 relaxation times between recurrent tumor and radiation necrosis |
Time Frame: | At end of scan (45 minuets after beginning study) |
Safety Issue: | |
Description: | |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Case Comprehensive Cancer Center |
Trial Keywords
- glioma
- brain tumor
- brain metastasis
Last Updated
December 16, 2020