Screening for Brain Metastases

ConditionsLung Cancer Stage IV Melanoma Stage IV Breast Cancer Metastatic

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Zurich

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

18 years or older on day of signing informed consent

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

gadopiclenol (contrast agent)
Other intervention
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.
standard contrast agent
Other intervention
as per local standard of care

Treatment groups

180 Participants

are divided into 2 treatment groups

Group A: gadopiclenol armActive comparator 1 intervention

Group B: standard contrast agent armExperimental treatment 1 intervention