Screening for Brain Metastases

NCT07492121 | Not Yet Recruiting Phase 2

• 1 other identifier: GAPIMET
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer Stage IV; Melanoma Stage IV; Breast Cancer Metastatic

Keywords

screening MRI

Outcome Measures

Primary Outcomes (1)

• Time interval between enrolment and diagnosis of CNS metastases

  from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months

Secondary Outcomes (7)

• Incidence of CNS 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

  from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months

• Description of the neurological assessment

  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

  from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months

• Safety and tolerability 1

  from randomization until one month after diagnosis of CNS metastasis event or up to a maximum of 25 months (one month after last MRI)

Other Outcomes (4)

• Liquid biopsy 1

  from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months

• Liquid biopsy 2

  from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months

• Artificial intelligence brain MRI analysis 1

  from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months

Study Arms (2)

gadopiclenol arm

ACTIVE COMPARATOR

Other: gadopiclenol (contrast agent)

standard contrast agent arm

EXPERIMENTAL

Other: standard contrast agent

Interventions

gadopiclenol (contrast agent) OTHER

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.

Also known as: elucirem

gadopiclenol arm

standard contrast agent OTHER

as per local standard of care

standard contrast agent arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically confirmed HER-2 positive or triple negative breast cancer, non-small cell lung cancer, or melanoma
• 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)
• 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
• years or older on day of signing informed consent
• Karnofsky performance status (KPS) ≥ 60
• Patients must have preserved renal function (serum creatinine \< 1.5 x ULN or creatinine clearance (CrCl) \> 30 mL/min (using the Cockcroft-Gault formula)
• 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.
• 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.
• 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.
• Written informed consent for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention.

You may not qualify if:

• Any contraindication to MRI, including claustrophobia
• Known severe adverse drug reaction or contraindication to gadolinium-based contrast agents
• 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.
• Heart failure: class III/IV NYHA
• Severe liver disease
• 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
• 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.
• Women who are pregnant or who breast feeding

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (2)

• Le Rhun E, Guckenberger M, Smits M, Dummer R, Bachelot T, Sahm F, Galldiks N, de Azambuja E, Berghoff AS, Metellus P, Peters S, Hong YK, Winkler F, Schadendorf D, van den Bent M, Seoane J, Stahel R, Minniti G, Wesseling P, Weller M, Preusser M; EANO Executive Board and ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. EANO-ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up of patients with brain metastasis from solid tumours. Ann Oncol. 2021 Nov;32(11):1332-1347. doi: 10.1016/j.annonc.2021.07.016. Epub 2021 Aug 6. No abstract available.

  PMID: 34364998 BACKGROUND

• Bendszus M, Roberts D, Kolumban B, Meza JA, Bereczki D, San-Juan D, Liu BP, Anzalone N, Maravilla K. Dose Finding Study of Gadopiclenol, a New Macrocyclic Contrast Agent, in MRI of Central Nervous System. Invest Radiol. 2020 Mar;55(3):129-137. doi: 10.1097/RLI.0000000000000624.

  PMID: 31917762 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Melanoma

Interventions

gadopiclenol; Contrast Media

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: March 25, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

CH (1)