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

Sponsor

University Medical Center Groningen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05864794

Collaborator

(none)

100

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer Metastatic	Diagnostic Test: MRI	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

ValUe of Screening MRI Brain in Patients With Newly Diagnosed Stage IV Non-oncogene Addicted Non-small Cell Lung CANcer

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Screening population 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.	Diagnostic Test: MRI MRI scan of the brain

Arm

Intervention/Treatment

Experimental: Screening population

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.

Diagnostic Test: MRI

MRI scan of the brain

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Medical Center Groningen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Medical Center Groningen

ClinicalTrials.gov Identifier:

NCT05864794

Other Study ID Numbers:

NL16776

First Posted:

May 18, 2023

Last Update Posted:

May 18, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Medical Center Groningen

brain metastasis

screening

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of May 18, 2023