Multi-Parametric Quantitative MR Imaging in Evaluation of Brain Tumors

NCT02956291 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CASE8316
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor

Keywords

glioma; brain tumor; brain metastasis

Outcome Measures

Primary Outcomes (5)

• T1 relaxometry value of Region of Interest (ROI) in MRF scan for each tumor type

  At end of scan (45 minuets after beginning study)

• T2 relaxometry value of Region of Interest (ROI) in MRF scan for each tumor type

  At end of scan (45 minuets after beginning study)

• Prediction analysis of MRF scans

  At 6 months

• Prediction analysis of MRF scans

  At 9 months

• Prediction analysis of MRF scans

  At 12 months

Secondary Outcomes (4)

• Number of patients whose clinical diagnosis and quantitative imaging diagnosis match

  At end of scan (45 minuets after beginning study)

• In treated tumors, difference in T1 relaxation times between baseline and 6 months post surgery

  6 months post-operative

• In treated tumors, difference in T2 relaxation times between baseline and 6 months post surgery

  6 months post-operative

• In treated tumors, difference in T1 and T2 relaxation times between recurrent tumor and radiation necrosis

  At end of scan (45 minuets after beginning study)

Study Arms (2)

Newly Diagnosed Brain Tumors

EXPERIMENTAL

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

Treated tumors with possible recurrence

EXPERIMENTAL

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

Interventions

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

Also known as: MRF, 3D-MRF, MRF relaxometry

Newly Diagnosed Brain Tumors; Treated tumors with possible recurrence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

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

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Glioma

Condition Hierarchy (Ancestors)

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

Study Officials

• Chaitra A Badve, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 7, 2016
• Study Start: February 15, 2017
• Primary Completion: April 17, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-10

Locations

US (1)