Using 7T MRI to detect melanoma spread to the brain
Pilot Study of 7T MRI for Early Diagnosis of Melanoma Brain Metastases
This study is testing if a stronger type of MRI can find melanoma that has spread to the brain better than the standard MRI.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Southern California Academic / other |
| Drugs / interventions | immunotherapy, radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04941430 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of 7-Tesla (7T) magnetic resonance imaging (MRI) in identifying melanoma that has metastasized to the brain. The study compares the diagnostic capabilities of 7T MRI with the standard 3T MRI, focusing on the detection of occult brain metastases at the time of diagnosis. Patients will undergo both imaging procedures within two weeks, allowing for a direct comparison of results. The trial aims to provide insights into the imaging characteristics of melanoma brain metastases and evaluate the incidence of leptomeningeal disease using 7T MRI.
Who should consider this trial
Good fit: Ideal candidates include melanoma patients aged 18 and older with newly diagnosed untreated brain metastases identified on standard 3T MRI.
Not a fit: Patients without brain metastases or those who have previously received treatment for brain metastases within the last 30 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate detection of melanoma brain metastases, improving patient outcomes.
How similar studies have performed: While the use of advanced MRI techniques is promising, this specific application of 7T MRI for melanoma brain metastases detection is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) * 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: * Patients who have had brain neurosurgery =\< 30 days prior to entering the study or those who have not recovered from adverse events related to that procedure * Patients who have had central nervous system (CNS)-directed radiotherapy =\< 30 days prior to entering the study or those who have not recovered from adverse events due to agents administered more than 30 days earlier * Patients with claustrophobia or anxiety limiting ability to tolerate MRI scans. Unable to tolerate MRI scan without use of anxiolytic medication or with distress requiring termination of scan or resulting in scans of poor quality * Patients with MRI-incompatible pacemakers or MRI-incompatible implants * History of allergic reactions attributed to compounds of similar chemical or biologic composition to gadolinium-based contrast agents (GBCA) or other agents used in study * Patients with poor renal function (estimated glomerular filtration rate \[eGFR\] \< 30) or requiring dialysis * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
Where this trial is running
Los Angeles, California
- USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Lindsay Hwang — University of Southern California
- Study coordinator: Lindsay Hwang
- Email: Lindsay.Hwang@med.usc.edu
- Phone: 323-409-5010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.