NCT07492121

Screening for Brain Metastases

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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	standard contrast agent	as per local standard of care

Timeline

• Start date: 2026-09-01
• Primary completion: 2029-06-01
• Completion: 2030-01-01
• First posted: 2026-03-25
• Last updated: 2026-03-25

Locations

1 site across 1 country: Switzerland