Detection of Brain Metastases Using a Novel Gadolinium-Weighted MRI Sequence: A Prospective Comparison (GDW)

January 29, 2026 updated by: Region Stockholm

A Prospective Comparative Study of a Novel Gadolinium-Weighted MRI Sequence Versus Conventional T1-Weighted Imaging for the Detection of Brain Metastases

This study will evaluate a new type of MRI sequence designed to improve the visibility of brain metastases after gadolinium contrast injection. The purpose is to determine whether this novel "gadolinium-weighted" imaging method can detect more or smaller tumors than standard MRI techniques. Participants will undergo a routine brain MRI with contrast, followed by an additional scan using the new method. The goal is to improve diagnostic accuracy without increasing the contrast dose or scan time.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Solna
      • Stockholm, Solna, Sweden, 1171 76

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients referred for clinical brain MRI with contrast at a university hospital radiology department in Sweden. Participants will be adults with known or suspected brain metastases undergoing routine post-gadolinium imaging as part of their diagnostic work-up.

Description

Inclusion Criteria:

  • Age 18 years or older
  • Scheduled for clinical brain MRI with gadolinium contrast
  • Known or suspected brain metastases
  • Able to provide informed consent
  • Able to lie still for the duration of the MRI examination

Exclusion Criteria:

  • Contraindications to MRI
  • Known allergy or contraindication to gadolinium-based contrast agents
  • Renal impairment (eGFR < 30 mL/min/1.73m²)
  • Pregnant or breastfeeding
  • Inability to comply with study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Suspected or Known Brain Metastases
Participants undergoing clinically indicated brain MRI with gadolinium contrast who will receive both conventional T1-weighted imaging and the novel gadolinium-weighted MRI sequence during the same scan session. The purpose is to compare lesion detection and conspicuity between the two sequences.
Diagnostic test: Novel Gadolinium-Weighted MRI Sequence
A post-contrast MRI sequence incorporating magnetization transfer (MT) preparation and flow-nulling with motion-sensitized driven equilibrium (MSDE). The sequence is optimized to suppress background tissue and vascular signal while enhancing the visibility of gadolinium-enhancing brain metastases. It is compared to conventional T1-weighted imaging in the same exam session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in Number of Detected Gadolinium-Enhancing Brain Metastases Between the Novel Gadolinium-Weighted MRI Sequence and Conventional T1-Weighted Imaging
Time Frame: At the time of gadolinium-enhanced MRI, during a single imaging session (within 1 hour of contrast administration)
At the time of gadolinium-enhanced MRI, during a single imaging session (within 1 hour of contrast administration)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Stockholm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 26, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Actual)

December 9, 2025

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K2025-9115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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