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7T MRI Scan for the Early Detection of Melanoma Brain Metastases

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04941430
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Southern California
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Lindsay Hwang
Principal Investigator Affiliation University of Southern California
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Malignant Neoplasm in the Brain, Metastatic Melanoma, Pathologic Stage IV Cutaneous Melanoma AJCC v8
Additional Details

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.

Arms & Interventions

Arms

Experimental: Diagnostic (7T MRI)

Within 2 weeks of initial standard of care 3T MRI, patients undergo 7T MRI scan with and without contrast over 1-2 hours.

Interventions

Diagnostic Test: - Magnetic Resonance Imaging using 7 Tesla MRI

Undergo 7T MRI

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

USC / Norris Comprehensive Cancer Center, Los Angeles, California

Status

Recruiting

Address

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Site Contact

Charlene Ketchens, RN

charlene.ketchens@med.usc.edu

323-865-3035