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.

Study Overview

• Status: Recruiting
• Conditions: Brain Tumor
• Intervention / Treatment: Device: Magnetic Resonance Fingerprinting

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.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chaitra A Badve, MD; Phone Number: 216-844-8140; Email: Chaitra.Badve@uhhospitals.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
      • Contact: Chaitra A Badve, MD; Phone Number: 216-844-8140; Email: Chaitra.Badve@uhhospitals.org
      • Principal Investigator: Chaitra A Badve, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Chaitra A Badve, MD, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2017
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: October 31, 2016
• First Submitted That Met QC Criteria: November 3, 2016
• First Posted (Estimated): November 6, 2016

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: glioma; brain tumor; brain metastasis
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: CASE8316

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No