Multi-Parametric Quantitative MR Imaging in Evaluation of Brain Tumors

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

- Patients with brain metastases undergoing partial brain radiation (gamma knife or SRS) with ability to undergo research scan at baseline, 1 month and , 3 months, and 6 months.

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02956291
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Case Comprehensive Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Chaitra A Badve, MD
Principal Investigator Affiliation	University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Tumor

Additional Details

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.

Arms & Interventions

Arms

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.

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.

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cleveland, Ohio

Status

Recruiting

Address

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106

Site Contact

Chaitra A Badve, MD

[email protected]

216-844-8140

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