Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-05850 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 10M-20-1 | Other Identifier | USC / Norris Comprehensive Cancer Center | |
| P30CA014089 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Insufficient Accrual
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
This clinical trial studies the use of 7-Tesla (7T) magnetic resonance imaging (MRI) in detecting melanoma that has spread to the brain (melanoma brain metastases). The standard MRI brain imaging is done on 3T or similar MRI machine, but the 7T MRI machine has a larger magnet which has been shown to have superior resolution of the brain and of non-cancerous brain lesions. Diagnostic procedures such as 7T MRI may help find and diagnose melanoma brain metastases earlier than standard 3T MRI.
PRIMARY OBJECTIVE:
I. Assess the potential superiority of contrast-enhanced (CE) 7T MRI by comparing to standard of care CE 3T MRI in detecting occult brain metastases lesion at time of diagnosis of new brain metastases.
SECONDARY OBJECTIVE:
I. Describe the imaging characteristics of melanoma brain metastases on 7T MRI of the brain.
EXPLORATORY OBJECTIVE:
I. Evaluate incidence of diagnosis of leptomeningeal disease on CE 7T MRI brain.
OUTLINE:
Within 2 weeks of initial standard of care 3T MRI, patients undergo 7T MRI scan with and without contrast over 1-2 hours.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (7T MRI) | Experimental | Within 2 weeks of initial standard of care 3T MRI, patients undergo 7T MRI scan with and without contrast over 1-2 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging using 7 Tesla MRI | Diagnostic Test | Undergo 7T MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence or absence of brain metastases on 7 tesla (T) magnetic resonance imaging (MRI) as compared to the standard of care 3T MRI | Any visualized brain metastases seen in this study on 3T will be evaluated using the criteria proposed by the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM). As there are no consensus criteria for 7T MRI published at this time, we will apply the same RANO-BM criteria to the study 7T MRI exams.Will count the discordant lesions between 3T and 7T, i.e. lesion identified in 7T but not 3T (L71L30) versus (vs.) lesion identified in 3T but not 7T(L70L31). McNemar's test will be used to compare L71L30 vs. L70L31. Will report 95% Clopper Pearson exact confidence interval for L71L30 vs. L70L31 in incidence of diagnosis of leptomeningeal disease. | Up to 14 days |
| Primary tumor size | Measured by study contrast enhanced (CE) 7T MRI compared to standard of care 3T MRI. | Up to 14 days |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of diagnosis of leptomeningeal disease on CE 7T MRI brain | Spaghetti plots will be used to illustrate the radiographic patterns of unique tumors. | At baseline |
Inclusion Criteria:
Melanoma patients with new untreated brain metastases seen on CE 3T MRI
Patient may have received previous systemic therapy, immunotherapy, or checkpoint inhibitors
Patient may have previous brain metastases treated >30 days prior with brain radiation, either whole brain radiation or radiosurgery
Age >= 18 years
Karnofsky performance status (KPS) >= 70
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Women of child-bearing potential need negative urine human chorionic gonadotropin (hCG) within 2 weeks prior to any treatment. A female of child-bearing potential is defined as any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Ability to tolerate MRI (able to lie flat in supine position without undue anxiety or discomfort or history of claustrophobia)
Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lindsay Hwang | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided