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Multi-Parametric Quantitative MR Imaging in Evaluation of Brain Tumors

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ClinicalTrials.gov Identifier: NCT02956291
Recruitment Status : Recruiting
First Posted : November 7, 2016
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Brain Tumor Device: Magnetic Resonance Fingerprinting Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multi-Parametric Quantitative MR Imaging in Evaluation of Brain Tumors
Actual Study Start Date : February 15, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Newly Diagnosed Brain Tumors
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.
Device: Magnetic Resonance Fingerprinting
Non-contrast MRF acquisition will be acquired through the region of tumor in all patients. For patients receiving intravenous gadolinium based contrast, a post contrast MRF acquisition will also be acquired. This acquisition will be skipped in patients who do not receive or are not eligible for receiving IV contrast as a part of their clinical scan. The research scan will take approximately 10-15 minutes
Other Names:
  • MRF
  • 3D-MRF
  • MRF relaxometry

Experimental: Treated tumors with possible recurrence
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.
Device: Magnetic Resonance Fingerprinting
Non-contrast MRF acquisition will be acquired through the region of tumor in all patients. For patients receiving intravenous gadolinium based contrast, a post contrast MRF acquisition will also be acquired. This acquisition will be skipped in patients who do not receive or are not eligible for receiving IV contrast as a part of their clinical scan. The research scan will take approximately 10-15 minutes
Other Names:
  • MRF
  • 3D-MRF
  • MRF relaxometry




Primary Outcome Measures :
  1. 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) ]
  2. T2 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) ]

Secondary Outcome Measures :
  1. Number of patients whose clinical diagnosis and quantitative imaging diagnosis match [ Time Frame: At end of scan (45 minuets after beginning study) ]
  2. In treated tumors, difference in T1 relaxation times between baseline and 6 months post surgery [ Time Frame: 6 months post-operative ]
  3. In treated tumors, difference in T2 relaxation times between baseline and 6 months post surgery [ Time Frame: 6 months post-operative ]
  4. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956291


Contacts
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Contact: Chaitra A Badve, MD 216-844-8140 Chaitra.Badve@uhhospitals.org

Locations
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United States, Ohio
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Chaitra A Badve, MD    216-844-8140    Chaitra.Badve@uhhospitals.org   
Principal Investigator: Chaitra A Badve, MD         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Chaitra A Badve, MD University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02956291     History of Changes
Other Study ID Numbers: CASE8316
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Case Comprehensive Cancer Center:
glioma
brain tumor
brain metastasis
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases