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Quantitative MRI for Blood Brain Barrier integrity Assessment without Gadolinium Based Contrast Agents

Quantitative MRI for Blood Brain Barrier integrity Assessment without Gadolinium Based Contrast Agents - MRI BBB Integrity assessment GBCA-Free

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56940
Enrollment
230
Registered
2024-08-09
Start date
2024-08-01
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hersenscan gebruikmakend van contrast parametric mapping in predicting the post-contrast enhancement in brain matter

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age => 18 year Patients from these pathologies will be included: * Brain Tumors. Rationale: Contrast MRI is instrumental in detecting brain tumors, as these agents help to delineate tumor margins, show the vascular supply, and highlight areas of neovascularity or breakdown of the normal blood-brain barrier. * Infections. Rationale: In cases of brain infections like abscesses, encephalitis, or meningitis, contrast MRI can help in defining the extent of the infection and differentiating it from other pathologies. * Multiple Sclerosis (MS). Rationale: For MS, contrast MRI can help in identifying active versus inactive lesions. Active lesions will typically take up the contrast agent due to the breakdown of the blood-brain barrier. * Inflammatory Conditions. Rationale: Diseases like sarcoidosis or autoimmune disorders such as vasculitis may also be evaluated with contrast MRI to understand the extent of inflammation and its effects on brain tissue. * Demyelinating Diseases. Rationale: Besides MS, other demyelinating conditions might also show contrast enhancement where there is active inflammation. * Metastasis. Rationale: Contrast MRI helps in the detection of metastatic cancer to the brain, often revealing multiple lesions with a characteristic appearance. * Post-Treatment Evaluation. Rationale: Following surgery, radiation, or chemotherapy, contrast MRI can help in monitoring for recurrence or progression of disease.

Exclusion criteria

Exclusion criteria: Patients with other pathologies even those which contrast agent is usually prescribed such as vascular malformations, aneurysms, congenital malformations and other vascular anomalies are excluded. A patient who meets any of the following criteria will be excluded from participation in this study: * Subjects with a typical contra-indication to an MRI exam. * Subjects with metal implants. * Subjects who have a documented allergy to MRI contrast media or a contra-indication for contrast-media or will not undergo contrast-enhanced MRI. * Woman who are pregnant or lactating * Having any physical or mental status that interferes with the informed consent procedure

Design outcomes

Primary

MeasureTime frame
Prediction of BBB breakdown

Secondary

MeasureTime frame
Evaluation of percentage of PD, T1 and T2 change related to the GBCA dose and patient*s weight.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)