NCT05864794

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
May 2024Jul 2026

First Submitted

Initial submission to the registry

April 17, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

May 13, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

May 23, 2024

Status Verified

May 1, 2024

Enrollment Period

1.3 years

First QC Date

April 17, 2023

Last Update Submit

May 22, 2024

Conditions

Non Small Cell Lung Cancer Metastatic

Keywords

brain metastasisscreening

Outcome Measures

Primary Outcomes (1)

  • Clinical value of the MRI

    Clinical value of the MRI evaluated by the treating thoracic oncologist and assessed by questionnaires completed on three timepoints.

    up to 6 months after the MRI

Study Arms (1)

Screening population

EXPERIMENTAL

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

Interventions

MRIDIAGNOSTIC_TEST

MRI scan of the brain

Screening population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9713LZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

F. Bensch, MD, PhD

CONTACT

0031503616161f.bensch@umcg.nl

L.B.M. Hijmering, MD

CONTACT

0031503616161l.b.m.hijmering-kappelle@umcg.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2023

First Posted

May 18, 2023

Study Start

May 13, 2024

Primary Completion

September 1, 2025

Study Completion (Estimated)

July 1, 2026

Last Updated

May 23, 2024

Record last verified: 2024-05

Locations

NL(1)