Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05864794

Value of Screening MRI Brain in Patients With Newly Diagnosed Stage IV Non-oncogene Addicted Non-small Cell Lung Cancer - The VULCAN Trial

Led by University Medical Center Groningen · Updated on 2024-05-23

100

Participants Needed

1

Research Sites

43 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients with newly diagnosed stage IV non-oncogene addicted non-small cell lung cancer (NSCLC) who are fit for systemic treatment and show no symptoms of brain disease. The study aims to evaluate the clinical value of performing a brain MRI scan as a screening tool in this patient group. This research is sponsored by the University Medical Center Groningen and focuses on using MRI to detect brain involvement up to six months after the scan. Participants will undergo an MRI scan of the brain as the main diagnostic test. This MRI is used to screen for brain disease in patients meeting the criteria. There is no comparison group or placebo; the focus is on the screening population only. The study assesses the impact and usefulness of the MRI scan results in this stage IV NSCLC population. During the study, participants will be monitored for up to six months after the MRI. Researchers will evaluate the clinical outcomes related to the MRI findings. Patients will be assessed according to standard clinical care, including physical status and symptoms. The total study duration and follow-up are designed to measure the value of brain MRI screening for these patients, including any changes or developments noted after the scan.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 assessed by the thoracic oncologist according to standard clinical care.
Not Eligible

You will not qualify if you...

  • Prior or concurrent therapy for stage IV disease.
  • Presence of oncogenic driver mutations such as EGFR, ALK, ROS1, RET, MET, or BRAF with approved targeted treatments.
  • Contraindications for MRI scan with contrast according to institutional protocols.

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - 1 day

Participants undergo an MRI scan of the brain to assess for brain disease.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 6 months

Participants are observed for up to 6 months after the MRI to evaluate clinical outcomes.

Trial Site Locations

Total: 1 location

1

University Medical Center Groningen

Groningen, Netherlands, 9713LZ

Actively Recruiting

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Research Team

F

F. Bensch, MD, PhD

L

L.B.M. Hijmering, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

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