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Brain TumorNCT02956291

Multi-Parametric Quantitative MR Imaging in Evaluation of Brain Tumors

A study testing Magnetic Resonance Fingerprinting in people with Brain Tumor, run by Case Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Tumor
What is being tested?
Magnetic Resonance Fingerprinting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
1 siteUnited States
Study dates
15 Feb 2017to 17 Apr 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site
  • University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106

Other trials in United States

About this study

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.

Read the 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.

Conditions
Brain Tumor
Being tested
Magnetic Resonance Fingerprinting
Keywords
glioma, brain tumor, brain metastasis
Medical subject headings
Brain Neoplasms, Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnetic Resonance FingerprintingDevice

    Also called MRF, 3D-MRF, MRF relaxometry

    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

Study groups in NCT02956291
Study groupRoleWhat they receive
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.
Receives: Device: Magnetic Resonance Fingerprinting
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.
Receives: Device: Magnetic Resonance Fingerprinting

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

Secondary outcomes (2)
  1. T1 Pre-contrast Relaxometry Value of Solid Tumor in MRF Scan for IDH1 Mutations in Glioma Tumor

    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.

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

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

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2016 (estimated)
  2. Study start15 Feb 2017
  3. Primary completion17 Apr 2025
  4. Study completion17 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02956291
Sponsor's protocol ID
CASE8316
Status last verified
Jul 2026
First submitted
31 Oct 2016
Last updated
25 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Magnetic Resonance Fingerprinting in people with Brain Tumor, run by Case Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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