Brain NeoplasmsGDWNCT07272616
Detection of Brain Metastases Using a Novel Gadolinium-Weighted MRI Sequence: A Prospective Comparison
An observational study of Brain Neoplasms, run by Region Stockholm at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Neoplasms
- What is being tested?
- Novel Gadolinium-Weighted MRI Sequence
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 28 Jan 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, Solna, 1171 76
Johan Lundberg, Associate professor, +46725802949, johan.h.lundberg@regionstockholm.se
About this study
Official title: 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.
- Conditions
- Brain Neoplasms
- Being tested
- Novel Gadolinium-Weighted MRI Sequence
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Gadolinium-Weighted MRI SequenceDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Novel Gadolinium-Weighted MRI Sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Number of Detected Gadolinium-Enhancing Brain Metastases Between the Novel Gadolinium-Weighted MRI Sequence and Conventional T1-Weighted Imaging
Measured: At the time of gadolinium-enhanced MRI, during a single imaging session (within 1 hour of contrast administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start28 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272616
- Sponsor's protocol ID
- K2025-9115
- Acronym
- GDW
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparative Study of a Novel Gadolinium-Weighted MRI Sequence Versus Conventional T1-Weighted Imaging for the Detection of Brain Metastases
- ClinicalTrials.gov ID
- NCT07272616
- Acronym / sponsor ID
- GDW / K2025-9115
- Conditions
- Brain Neoplasms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Suspected or Known Brain Metastases | – | Diagnostic Test: Novel Gadolinium-Weighted MRI SequenceParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel Gadolinium-Weighted MRI SequenceA 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. | Diagnostic test | Patients with Suspected or Known Brain Metastases |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Brain Neoplasms
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Neoplasms, run by Region Stockholm at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.