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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Enrollment
180
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.
as per local standard of care
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland
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
Incidence of CNS metastases
presence of brain metastases or leptomeningeal metastases
Time frame: 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
brain metastases, leptomeningeal metastases, both; and the number of measurable and non-measurable brain metastases
Time frame: from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months
Description of the neurological assessment
symptomatic versus asymptomatic; steroid consumption, Karnofsky performance status (KPS)
Time frame: 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
based on the pre-therapeutic imaging as compared to the diagnostic brain metastases imaging
Time frame: from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months
Safety and tolerability 1
adverse events (CTCAE v5.0)
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)
Safety and tolerability 2
short patient self-questionnaire on the tolerance of MRI
Time frame: from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months
Qualitative assessment of images by the neuroradiologist
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
Time frame: from randomization until diagnosis of CNS metastasis event or up to a maximum of 24 months
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