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Multi-Parametric Quantitative MR Imaging in Evaluation of Brain Tumors

Primary Purpose

Brain Tumor

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Magnetic Resonance Fingerprinting

About this trial

This is an interventional diagnostic trial for Brain Tumor focused on measuring glioma, brain tumor, brain metastasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Newly Diagnosed Brain Tumors

Treated tumors with possible recurrence

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Number of patients whose clinical diagnosis and quantitative imaging diagnosis match

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

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

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

Full Information

NCT ID

NCT02956291

First Posted

October 31, 2016

Last Updated

June 26, 2023

Sponsor

Case Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT02956291

Brief Title

Multi-Parametric Quantitative MR Imaging in Evaluation of Brain Tumors

Official Title

Multi-Parametric Quantitative MR Imaging in Evaluation of Brain Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 15, 2017 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Tumor

Keywords

glioma, brain tumor, brain metastasis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Newly Diagnosed Brain Tumors

Arm Type

Experimental

Arm Description

Arm Title

Treated tumors with possible recurrence

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Magnetic Resonance Fingerprinting

Other Intervention Name(s)

MRF, 3D-MRF, MRF relaxometry

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

At end of scan (45 minuets after beginning study)

Title

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

Time Frame

At end of scan (45 minuets after beginning study)

Secondary Outcome Measure Information:

Title

Number of patients whose clinical diagnosis and quantitative imaging diagnosis match

Time Frame

At end of scan (45 minuets after beginning study)

Title

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

Time Frame

6 months post-operative

Title

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

Time Frame

6 months post-operative

Title

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

Time Frame

At end of scan (45 minuets after beginning study)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chaitra A Badve, MD

Phone

216-844-8140

Chaitra.Badve@uhhospitals.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chaitra A Badve, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chaitra A Badve, MD

Phone

216-844-8140

Chaitra.Badve@uhhospitals.org

First Name & Middle Initial & Last Name & Degree

Chaitra A Badve, MD

12. IPD Sharing Statement

Learn more about this trial

Multi-Parametric Quantitative MR Imaging in Evaluation of Brain Tumors

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