Clinical Trials /

Multi-Parametric Quantitative MR Imaging in Evaluation of Brain Tumors

NCT02956291

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.

Related Conditions:
  • Brain Neoplasm
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

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

  • Brain Tumor

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 evaluate the utility of quantitative MRI imaging
      including 3D-MRF in differentiating among different untreated brain tumors and
      differentiating recurrent brain tumor (TR) from treatment effects.

      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

NameTypeDescriptionInterventions
Newly Diagnosed Brain TumorsExperimentalParticipants 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 recurrenceExperimentalParticipants 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
      
              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.
      
                -  History of allergic reactions attributed to compounds of similar chemical or biologic
                   composition to MR contrast material.
      
                -  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:Early Phase 1
      Primary Purpose:Interventional
      Overall Status:Not yet recruiting
      Lead Sponsor:Case Comprehensive Cancer Center

      Trial Keywords

      • glioma
      • brain tumor
      • brain metastasis

      Last Updated

      November 3, 2016