To compare the clinical value of MR quantitative parametric maps versus the use of GBCA MRI.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Hersenscan gebruikmakend van contrast
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Prediction of BBB breakdown
Secondary outcome
Evaluation of percentage of PD, T1 and T2 change related to the GBCA dose and
patient*s weight.
Background summary
The Magnetic Resonance (MR) Physics research group has identified a potential
biomarker based on non-invasive quantitative MRI technique that could assess
the blood brain barrier integrity without the necessity of toxic gadolinium
based contrast agents (GBCAs). A first endpoint is to verify the ability of
quantitative parametric mapping in predicting the post-contrast enhancement,
previous to the GBCA injection. A second endpoint is to evaluate the effective
quantitative percentage of change in the post-contrast T1 and T2 value due to
the GBCA. The rational of GBCA is to shorten the natural long T1 and T2 values.
The evaluation of the percentage of change of T1 due to the GBCA could
facilitate a new model where the administered GBCA dose could be reduced to
that amount that produces a minimum detectable percentage of change with MRI.
To evaluate the clinical value of this new approach, this new biomarker for BBB
integrity has to be compared to the conventional use of GBCA in large cohort of
patients who undergone MRI with contrast agent because the current clinical
state of the art.
Study objective
To compare the clinical value of MR quantitative parametric maps versus the use
of GBCA MRI.
Study design
Observational diagnostic study.
Study burden and risks
Burden: 5 extra minutes MRI examination . No risk associated, Potential benefit
for those patients with recurrent MRI exams with contrast agent who could
potentially not need dose of GBCA in future visits or , at least, a smaller
amount of GBCA based on the quantitative detection of the percentage of change
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86761.078.24 |