Skip to main content
OpenTrials
Completed

NCT Number: NCT02956291

Multi-Parametric Quantitative MR Imaging in Evaluation of Brain Tumors

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Brain Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Glioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnetic Resonance Fingerprinting

Device

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 outcomes

  1. T1 Pre-contrast Relaxometry Value of Solid Tumor in MRF Scan for Each Tumor Type

    Time frame: At end of scan (45 minutes after beginning study)

    Relaxometry time is the measurement of relaxation times from MR images and is the quantitative imaging technique that measures the exact T1 and T2 times of tissue.: T1 and T2 are imaging sequences. T1 is used for visualizing clear anatomy and fat, while T2 is used for detecting inflammation, edema and fluid buildup.

  2. T2 Pre-contrast Relaxometry Value of Solid Tumor in MRF Scan for Each Tumor Type

    Time frame: At end of scan (45 minutes after beginning study)

    Relaxometry time is the measurement of relaxation times from MR images and is the quantitative imaging technique that measures the exact T1 and T2 times of tissue.: T1 and T2 are imaging sequences. T1 is used for visualizing clear anatomy and fat, while T2 is used for detecting inflammation, edema and fluid buildup.

  3. T1 Post-contrast Relaxometry Value of Solid Tumor Region in MRF Scan for Each Tumor Type

    Time frame: At end of scan (45 minutes after beginning study)

    Relaxometry time is the measurement of relaxation times from MR images and is the quantitative imaging technique that measures the exact T1 and T2 times of tissue.: T1 and T2 are imaging sequences. T1 is used for visualizing clear anatomy and fat, while T2 is used for detecting inflammation, edema and fluid buildup.

  4. T2 Post-contrast Relaxometry Value of Solid Tumor in MRF Scan for Each Tumor Type

    Time frame: At end of scan (45 minutes after beginning study)

    Relaxometry time is the measurement of relaxation times from MR images and is the quantitative imaging technique that measures the exact T1 and T2 times of tissue.: T1 and T2 are imaging sequences. T1 is used for visualizing clear anatomy and fat, while T2 is used for detecting inflammation, edema and fluid buildup.

  5. T1 Pre-contrast Relaxometry Value of Peritumoral White Matter in MRF Scan for Each Tumor Region

    Time frame: At end of scan (45 minutes after beginning study)

    Relaxometry time is the measurement of relaxation times from MR images and is the quantitative imaging technique that measures the exact T1 and T2 times of tissue.: T1 and T2 are imaging sequences. T1 is used for visualizing clear anatomy and fat, while T2 is used for detecting inflammation, edema and fluid buildup.

  6. T2 Pre-contrast Relaxometry Value of Peritumoral White Matter in MRF Scan for Each Tumor Region

    Time frame: At end of scan (45 minutes after beginning study)

    Relaxometry time is the measurement of relaxation times from MR images and is the quantitative imaging technique that measures the exact T1 and T2 times of tissue.: T1 and T2 are imaging sequences. T1 is used for visualizing clear anatomy and fat, while T2 is used for detecting inflammation, edema and fluid buildup.

  7. T1 Post-contrast Relaxometry Value of Peritumoral White Matter in MRF Scan for Each Tumor Region

    Time frame: At end of scan (45 minutes after beginning study)

    Relaxometry time is the measurement of relaxation times from MR images and is the quantitative imaging technique that measures the exact T1 and T2 times of tissue.: T1 and T2 are imaging sequences. T1 is used for visualizing clear anatomy and fat, while T2 is used for detecting inflammation, edema and fluid buildup.

  8. T2 Post-contrast Relaxometry Value of Peritumoral White Matter in MRF Scan for Each Tumor Region

    Time frame: At end of scan (45 minutes after beginning study)

    Relaxometry time is the measurement of relaxation times from MR images and is the quantitative imaging technique that measures the exact T1 and T2 times of tissue.: T1 and T2 are imaging sequences. T1 is used for visualizing clear anatomy and fat, while T2 is used for detecting inflammation, edema and fluid buildup.

  9. T1 Pre-contrast Relaxometry Value of Solid Tumor in MRF Scan for Each Glioma Tumor Grade

    Time frame: At end of scan (45 minutes after beginning study)

    Relaxometry time is the measurement of relaxation times from MR images and is the quantitative imaging technique that measures the exact T1 and T2 times of tissue.: T1 and T2 are imaging sequences. T1 is used for visualizing clear anatomy and fat, while T2 is used for detecting inflammation, edema and fluid buildup.

  10. T2 Pre-contrast Relaxometry Value of Solid Tumor in MRF Scan for Each Glioma Tumor Grade

    Time frame: At end of scan (45 minuets after beginning study)

    Relaxometry time is the measurement of relaxation times from MR images and is the quantitative imaging technique that measures the exact T1 and T2 times of tissue.: T1 and T2 are imaging sequences. T1 is used for visualizing clear anatomy and fat, while T2 is used for detecting inflammation, edema and fluid buildup.

  11. T1 Post-contrast Relaxometry Value of Solid Tumor Region in MRF Scan for Each Glioma Tumor Grade

    Time frame: At end of scan (45 minutes after beginning study)

    Relaxometry time is the measurement of relaxation times from MR images and is the quantitative imaging technique that measures the exact T1 and T2 times of tissue.: T1 and T2 are imaging sequences. T1 is used for visualizing clear anatomy and fat, while T2 is used for detecting inflammation, edema and fluid buildup.

  12. T2 Post-contrast Relaxometry Value of Solid Tumor in MRF Scan for Each Glioma Tumor Grade

    Time frame: At end of scan (45 minutes after beginning study)

    Relaxometry time is the measurement of relaxation times from MR images and is the quantitative imaging technique that measures the exact T1 and T2 times of tissue.: T1 and T2 are imaging sequences. T1 is used for visualizing clear anatomy and fat, while T2 is used for detecting inflammation, edema and fluid buildup.

Secondary outcomes

  1. T1 Pre-contrast Relaxometry Value of Solid Tumor in MRF Scan for IDH1 Mutations in Glioma Tumor

    Time frame: At end of scan (45 minutes after beginning study)

    Relaxometry time is the measurement of relaxation times from MR images and is the quantitative imaging technique that measures the exact T1 and T2 times of tissue.: T1 and T2 are imaging sequences. T1 is used for visualizing clear anatomy and fat, while T2 is used for detecting inflammation, edema and fluid buildup.

  2. T1 Pre-contrast Relaxometry Value of Solid Tumor in MRF Scan for ATRX Mutations in Glioma Tumor

    Time frame: At end of scan (45 minutes after beginning study)

    Relaxometry time is the measurement of relaxation times from MR images and is the quantitative imaging technique that measures the exact T1 and T2 times of tissue.: T1 and T2 are imaging sequences. T1 is used for visualizing clear anatomy and fat, while T2 is used for detecting inflammation, edema and fluid buildup.

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Nov 7, 2016
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.