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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-06374 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2019-1032 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial investigates how well 7T MRI scan works in imaging central nervous system tumors. Diagnostic procedures, such as 7T MRI, may help find and diagnose central nervous system tumors and help measure a patient's response to earlier treatment. The goal of this trial is to learn if a new MRI system can provide better quality images than a standard MRI.
PRIMARY OBJECTIVE:
I. To estimate the contrast-to-noise ratio (CNR) for several imaging modalities in brain malignancy as compared with normal brain parenchyma separately by type of malignancy and treatment status.
SECONDARY OBJECTIVE:
I. To assess the conspicuity of each imaging modality to differentiate radiation necrosis from progressive disease.
EXPLORATORY OBJECTIVES:
I. To assess patient experience in the 7 Tesla (7T) magnetic resonance imaging (MRI) system compared to their most recent MRI examination.
II. To assess the typical significance values seen for areas of maximal brain activity associated with each functional MRI (fMRI) test.
III. To assess the geometric distortion of a radiation planning sequence on a ultra-high field (UHF) system.
OUTLINE:
Patients undergo 7T MRI over 60 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (7T MRI) | Experimental | Patients undergo 7T MRI over 60 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7 Tesla Magnetic Resonance Imaging | Procedure | Undergo 7T MRI |
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| Measure | Description | Time Frame |
|---|---|---|
| Contrast-to-noise Ratio (CNR) | Contrast-to-noise ratio (CNR) refers to the difference in signal intensity between the tumor and surrounding tissue. Higher CNR values indicate better image quality. | 1 year |
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Inclusion Criteria:
Adult patients must meet one set of inclusion criteria:
Newly identified and untreated central nervous system glioma or metastasis of at least 5 mm or greater in size
History of central nervous system glioma or metastasis treated with surgery, radiation, chemotherapy, or immunotherapy with new or increasing signal on MR imaging that is suspicious for progressive disease (treatment failure)
Exclusion Criteria:
Contraindication to MR imaging
Absolute or relative contra-indication to 3T MRI due to metallic foreign bodies and devices and/or other conditions that are not MR safe, which include implants with unknown behavior in 3T MRI as well as:
Pregnancy
Claustrophobia that does not readily respond to oral medication
Known allergy to gadolinium-based contrast agents
Renal failure as defined by a glomerular filtration rate (GFR) less than 30 or the use of hemodialysis
Pregnant
Interval treatment with radiation or surgery between the diagnostic MRI lesion identification and planned study MRI
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| Name | Affiliation | Role |
|---|---|---|
| Max Wintermark | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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Patients 13 years old and above with newly identified and untreated primary brain tumor or metastasis of at least 5 mm or greater in size. Up to twenty (20) healthy volunteers will be studied for the purposes of MRI sequence optimization
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Healthy Volunteers |
| FG001 | Group 2 | Patients (13 years old and above) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 25, 2023 |
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| Questionnaire Administration | Other | Ancillary studies |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Healthy Volunteers |
| BG001 | Group 2 | Patients (13 years old and above) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Contrast-to-noise Ratio (CNR) | Contrast-to-noise ratio (CNR) refers to the difference in signal intensity between the tumor and surrounding tissue. Higher CNR values indicate better image quality. | Posted | Mean | Standard Deviation | contrast-to-noise ratio | 1 year |
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Healthy Volunteers | 0 | 8 | 0 | 8 | 0 | 8 |
| EG001 | Group 2 | Patients (13 years old and above) | 0 | 30 | 0 | 30 | 0 | 30 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Max Wintermark, MD | M.D. Anderson Cancer Center | 713-792-0845 | mwintermark@mdanderson.org |
| Sep 24, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 7, 2023 | Oct 24, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D005910 | Glioma |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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