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