Value of Screening MRI Brain in Stage IV Non-small Cell Lung Cancer

Not Applicable

Recruiting

• Conditions: Non Small Cell Lung Cancer Metastatic
• Interventions: Diagnostic Test: MRI

• Registration Number: NCT05864794
• Lead Sponsor: University Medical Center Groningen

Brief Summary

Patients with newly diagnosed stage IV non-oncogene addicted NSCLC, who are fit for systemic treatment and don't have any symptoms of brain disease will undergo an MRI of the brain to screen for brain disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-17
• Study First Submitted QC: 2023-05-16
• Study First Posted: 2023-05-18
• Status Verified: 2024-05
• Study Start: 2024-05-13
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-23
• Primary Completion: 2025-09-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Histologically or cytologically confirmed stage IV metastatic NSCLC, not amenable to curative treatment.
• Fit for systemic treatment (PS 0-2) according to standard of care.
• No symptoms of brain disease disease assessed according to standard clinical care by the thoracic oncologist.

Exclusion Criteria

• Prior/concomitant therapy for stage IV disease.
• Oncogenic diver mutation (e.g. EGFR, ALK, ROS1, RET, MET, and BRAF) with approved targeted treatment.
• Contraindications for MRI scan with contrast as per standard of care protocol of the institution.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening population	MRI	Patients with newly diagnosed stage IV non-oncogene addicted NSCLC, who are fit for systemic treatment and don't have any symptoms of brain disease.

Primary Outcome Measures

Name	Time	Method
Clinical value of the MRI	up to 6 months after the MRI	Clinical value of the MRI evaluated by the treating thoracic oncologist and assessed by questionnaires completed on three timepoints.

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands