TERMINATED

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pilot Study of 7T MRI for Early Diagnosis of Melanoma Brain Metastases

Quick Facts

Study Start:2021-06-25

Study Completion:2025-01-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT04941430

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Lindsay Hwang

PRINCIPAL_INVESTIGATOR

University of Southern California

Study Locations (Sites)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033

United States

Collaborators and Investigators

Sponsor: University of Southern California

Lindsay Hwang, PRINCIPAL_INVESTIGATOR, University of Southern California

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-25

Study Completion Date2025-01-10

Study Record Updates

Study Start Date2021-06-25

Study Completion Date2025-01-10

Terms related to this study

Additional Relevant MeSH Terms

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