Brain Tumor
Conditions
Keywords
glioma, brain tumor, brain metastasis
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.
Interventions
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
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| T1 Pre-contrast Relaxometry Value of Solid Tumor in MRF Scan for Each Tumor Type | 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. |
| T2 Pre-contrast Relaxometry Value of Solid Tumor in MRF Scan for Each Tumor Type | 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. |
| T1 Post-contrast Relaxometry Value of Solid Tumor Region in MRF Scan for Each Tumor Type | 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. |
| T2 Post-contrast Relaxometry Value of Solid Tumor in MRF Scan for Each Tumor Type | 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. |
| T1 Pre-contrast Relaxometry Value of Peritumoral White Matter in MRF Scan for Each Tumor Region | 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. |
| T2 Pre-contrast Relaxometry Value of Peritumoral White Matter in MRF Scan for Each Tumor Region | 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. |
| T1 Post-contrast Relaxometry Value of Peritumoral White Matter in MRF Scan for Each Tumor Region | 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. |
| T2 Post-contrast Relaxometry Value of Peritumoral White Matter in MRF Scan for Each Tumor Region | 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. |
| T1 Pre-contrast Relaxometry Value of Solid Tumor in MRF Scan for Each Glioma Tumor Grade | 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. |
| T2 Pre-contrast Relaxometry Value of Solid Tumor in MRF Scan for Each Glioma Tumor Grade | 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. |
| T1 Post-contrast Relaxometry Value of Solid Tumor Region in MRF Scan for Each Glioma Tumor Grade | 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. |
| T2 Post-contrast Relaxometry Value of Solid Tumor in MRF Scan for Each Glioma Tumor Grade | 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
| Measure | Time frame | Description |
|---|---|---|
| T1 Pre-contrast Relaxometry Value of Solid Tumor in MRF Scan for IDH1 Mutations in Glioma Tumor | 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. |
| T1 Pre-contrast Relaxometry Value of Solid Tumor in MRF Scan for ATRX Mutations in Glioma Tumor | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChaitra A Badve, MD
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 20-29 years | 8 Participants |
| Age, Customized 30-39 years | 11 Participants |
| Age, Customized 40-49 years | 20 Participants |
| Age, Customized 50-59 years | 45 Participants |
| Age, Customized 60-69 years | 50 Participants |
| Age, Customized 70-79 years | 30 Participants |
| Age, Customized 80-89 years | 4 Participants |
| Age, Customized 90-99 years | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 169 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 156 Participants |
| Sex: Female, Male Female | 76 Participants |
| Sex: Female, Male Male | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 170 |
| other Total, other adverse events | 0 / 170 |
| serious Total, serious adverse events | 0 / 170 |
Outcome results
None listed