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

NCT07272616 | Recruiting

• 1 other identifier: K2025-9115
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Neoplasms

Outcome Measures

Primary Outcomes (1)

• Difference in Number of Detected Gadolinium-Enhancing Brain Metastases Between the Novel Gadolinium-Weighted MRI Sequence and Conventional T1-Weighted Imaging

  At the time of gadolinium-enhanced MRI, during a single imaging session (within 1 hour of contrast administration)

Study Arms (1)

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

Interventions

Novel Gadolinium-Weighted MRI Sequence DIAGNOSTIC_TEST

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.

Patients with Suspected or Known Brain Metastases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Stockholm: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, Solna, 1171 76, Sweden

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: January 28, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 30, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)