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

Primary Purpose

Non Small Cell Lung Cancer Metastatic

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRI
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Non Small Cell Lung Cancer Metastatic focused on measuring brain metastasis, screening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Screening population

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    April 17, 2023
    Last Updated
    July 10, 2023
    Sponsor
    University Medical Center Groningen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05864794
    Brief Title
    Value of Screening MRI Brain in Stage IV Non-small Cell Lung Cancer
    Acronym
    VULCAN
    Official Title
    ValUe of Screening MRI Brain in Patients With Newly Diagnosed Stage IV Non-oncogene Addicted Non-small Cell Lung CANcer - The VULCAN Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Medical Center Groningen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non Small Cell Lung Cancer Metastatic
    Keywords
    brain metastasis, screening

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Screening population
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    MRI
    Intervention Description
    MRI scan of the brain
    Primary Outcome Measure Information:
    Title
    Clinical value of the MRI
    Description
    Clinical value of the MRI evaluated by the treating thoracic oncologist and assessed by questionnaires completed on three timepoints.
    Time Frame
    up to 6 months after the MRI

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    F. Bensch, MD, PhD
    Phone
    0031503616161
    Email
    f.bensch@umcg.nl
    First Name & Middle Initial & Last Name or Official Title & Degree
    L.B.M. Hijmering, MD
    Phone
    0031503616161
    Email
    l.b.m.hijmering-kappelle@umcg.nl

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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