New MRI dye could spot brain tumors sooner in cancer patients
NCT ID NCT07492121
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a new MRI contrast agent, gadopiclenol, can detect brain metastases earlier than standard methods in 180 patients with advanced lung, breast, or skin cancer. Participants will receive screening brain MRIs to compare diagnosis timing and accuracy. The goal is to find brain tumors sooner, potentially offering more treatment options and better quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with histologically confirmed HER-2 positive or triple negative breast cancer, non-small cell lung cancer, or melanoma 2. Up to 3 months after diagnosis of a cancer at high risk of CNS metastasis with indication for screening and follow-up by MRI (based on a high risk of CNS metastases according to EANO ESMO brain metastases guidelines: stage IV HER-2 positive or triple negative breast, stage II to IV lung cancer, stage IV melanoma) 3. Enrolment at the time of initiation of screening and follow-up MRI: usually, but not necessarily at the time of new diagnosed stage IV HER-2 positive or triple negative breast, lung cancer, melanoma 4. 18 years or older on day of signing informed consent 5. Karnofsky performance status (KPS) ≥ 60 6. Patients must have preserved renal function (serum creatinine \< 1.5 x ULN or creatinine clearance (CrCl) \> 30 mL/min (using the Cockcroft-Gault formula) 7. Women of child-bearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test before the MRI. 8. Patients of childbearing / reproductive potential must agree to use adequate birth control measures, as defined by the investigator, during the study period and for at least 6 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. 9. Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments. 10. Written informed consent for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention. Exclusion Criteria: 1. Any contraindication to MRI, including claustrophobia 2. Known severe adverse drug reaction or contraindication to gadolinium-based contrast agents 3. Acute or chronic renal insufficiency: grade III or more (eGFR \<60 mL/min/1.73 m2) based on one eGFR assessment performed within one day the MRI prior to the first contrast agent injection. 4. Heart failure: class III/IV NYHA 5. Severe liver disease 6. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements 7. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. 8. Women who are pregnant or who breast feeding
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Hospital Zurich
Zurich, Canton of Zurich, 8091, Switzerland
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