Clinical Stage IV Cutaneous Melanoma AJCC v8NCT04941430

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

A study testing Magnetic Resonance Imaging using 7 Tesla MRI in people with Clinical Stage IV Cutaneous Melanoma AJCC v8 and Metastatic Malignant Neoplasm in the Brain, run by University of Southern California at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Malignant Neoplasm in the Brain, Metastatic Melanoma
What is being tested?: Magnetic Resonance Imaging using 7 Tesla MRI
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteUnited States
Study dates: 25 Jun 2021to 10 Jan 2025
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

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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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

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:

Describe the imaging characteristics of melanoma brain metastases on 7T MRI of the brain.

EXPLORATORY OBJECTIVE:

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.

Conditions: Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Malignant Neoplasm in the Brain, Metastatic Melanoma, Pathologic Stage IV Cutaneous Melanoma AJCC v8
Being tested: Magnetic Resonance Imaging using 7 Tesla MRI
Medical subject headings: Brain Neoplasms, Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Magnetic Resonance Imaging using 7 Tesla MRIDiagnostic test
Also called 7 Tesla MRI, 7T MRI
Undergo 7T MRI

Study groups in NCT04941430
Study group	Role	What they receive
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. Receives: Diagnostic Test: Magnetic Resonance Imaging using 7 Tesla MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 14 days
Primary tumor size
Measured by study contrast enhanced (CE) 7T MRI compared to standard of care 3T MRI.
Measured: Up to 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jun 202110 Jan 2025

First posted28 Jun 2021
Study start25 Jun 2021
Primary completion10 Jan 2025
Study completion10 Jan 2025

Why it stopped: Insufficient Accrual

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Clinical Stage IV Cutaneous Melanoma AJCC v8Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04941430
Sponsor's protocol ID: 10M-20-1
Other IDs: NCI-2021-05850, 10M-20-1, P30CA014089
Status last verified: Aug 2025
First submitted: 18 Jun 2021
Last updated: 12 Aug 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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