Screening for Brain Metastases (GAPIMET)

March 18, 2026 updated by: University of Zurich

Quality and Safety of Screening for Brain Metastases by Gadopiclenol in Patients With Cancer at High Risk of Developing Brain Metastases

The survival of patients with CNS metastases often remains limited to some months. CNS metastases are also associated with neurological decline and decrease of quality of life. An early identification of CNS metastases may potentially lead to more therapeutic options and prevent or delay the development of neurological symptoms and signs. Patients with cancer associated with a high risk of developing CNS metastasis will be enrolled in this trial. These patients are candidates for a screening brain MRI program in the routine management as recommended in current guidelines (Le Rhun et al. 2021) (Amaral et al. 2025, "ESMO Living Guideline: Cutaneous Melanoma, v1.0 February 2025").

The primary objective is to compare the time to CNS metastases diagnosis detected by MRI using different contrast agents (of gadopiclenol at a dose of 0.1 mmol/kg over current standard practice ) in patients with cancer considered at high risk of developing brain metastases.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: gadopiclenol arm
Other: gadopiclenol (contrast agent)
Gadopiclenol is a contrast agent approved in Switzerland. In this study, a double-dose of gadopiclenol will be used: 0.2 mL body weight (equivalent to 0.1 mmol/kg BW) at the time of the screening brain MRI.
Other Names:
  • elucirem
Experimental: standard contrast agent arm
Other: standard contrast agent
as per local standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time interval between enrolment and diagnosis of CNS metastases
Time Frame: from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months
from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of CNS metastases
Time Frame: from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months
presence of brain metastases or leptomeningeal metastases
from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months
Assessment of the type of CNS metastases at the time of CNS event
Time Frame: from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months
brain metastases, leptomeningeal metastases, both; and the number of measurable and non-measurable brain metastases
from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months
Description of the neurological assessment
Time Frame: from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months
symptomatic versus asymptomatic; steroid consumption, Karnofsky performance status (KPS)
from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months
Assessment of the rate of diagnostic procedures triggered by the results and the rate of modifications of therapeutic decision making
Time Frame: from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months
based on the pre-therapeutic imaging as compared to the diagnostic brain metastases imaging
from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months
Safety and tolerability 1
Time Frame: from randomization until one month after diagnosis of CNS metastasis event or up to a maximum of 25 months (one month after last MRI)
adverse events (CTCAE v5.0)
from randomization until one month after diagnosis of CNS metastasis event or up to a maximum of 25 months (one month after last MRI)
Safety and tolerability 2
Time Frame: from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months
short patient self-questionnaire on the tolerance of MRI
from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months
Qualitative assessment of images by the neuroradiologist
Time Frame: from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months
overall visualization and characterization of the lesion; lesion border delineation; internal morphology; degree of contrast enhancement; technical image adequacy for diagnosis; diagnosis and confidence assigned to the diagnosis; overall diagnostic comfort
from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liquid biopsy 1
Time Frame: from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months
Cell-free DNA (cfDNA)
from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months
Liquid biopsy 2
Time Frame: from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months
Extracellular vesicles (EV)
from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months
Artificial intelligence brain MRI analysis 1
Time Frame: from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months
Determination of early MRI characteristics of brain metastases
from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months
Artificial intelligence brain MRI analysis 2
Time Frame: from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months
Exploration of the prediction of the tumor growth
from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

September 25, 2025

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 25, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAPIMET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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