Improving diagnosis of splanchnic vein thrombosis using MRDTI
Optimizing Diagnosis of Splanchic Vein Thrombosis With MR Direct Thrombus Imaging, the Rhea Study
This study is testing a new imaging method called MR Direct Thrombus Imaging to see if it can better diagnose splanchnic vein thrombosis in patients when other imaging techniques don't work well.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 73 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 3 sites (Rome and 2 other locations) |
| Trial ID | NCT06390475 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study aims to evaluate the effectiveness of MR Direct Thrombus Imaging (MRDTI) in diagnosing splanchnic vein thrombosis (SVT), particularly in cases where traditional imaging methods fall short. The study will assess the sensitivity of MRDTI in identifying both acute and chronic SVT, including incidental findings. By establishing the accuracy of this technique, the researchers hope to enhance diagnostic precision and inform treatment decisions regarding anticoagulant therapy for patients with SVT.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed acute or chronic splanchnic vein thrombosis.
Not a fit: Patients with contraindications for MRI or those with severe comorbid conditions that prevent participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of splanchnic vein thrombosis, allowing for better-targeted treatments and improved patient outcomes.
How similar studies have performed: While MR angiography has shown promise in diagnosing SVT, the MRDTI approach is relatively novel and has not been extensively tested in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with confirmed acute SVT; definitions provided in paragraph 4.2 (Cases, group 1) 2. Patients with confirmed non-symptomatic chronic SVT defined by incident SVT with chronic thrombi on 2 serial imaging tests with at least 3 months interval (controls, group 2) 3. Aged 18 years and older 4. Willing and able to give informed consent Exclusion Criteria: 1. MRI contra-indication (including but not limited to a cardiac pacemaker or subcutaneous defibrillator; vascular clips in the cerebral vessels; metal splinter in the eye, a hearing aid that cannot be removed; a neurostimulator that cannot be removed; a hydrocephalus pump) 2. A medical condition, associated illness or co-morbid circumstances that precludes completion of the study procedures (MRI and 90-day follow-up assessment), including but not limited to lifeexpectancy less than 3 months, inability to lie flat, morbid obesity preventing use of MR and claustrophobia. 3. Patients with decompensated liver disease with Child-Pugh class C cirrhosis (since MRDTI evaluation will be inadequate in these patients) 4. Patients with suspected tumour thrombus
Where this trial is running
Rome and 2 other locations
- Gemelli Hospital — Rome, Italy (Recruiting)
- Varese hospital — Varese, Italy (Recruiting)
- Erasmus Medisch Centrum — Rotterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: F.A. Klok, Prof. — Study Principal Investigator
- Study coordinator: S.N.M. ter Haar, MD
- Email: s.n.m.ter_haar@lumc.nl
- Phone: 0031-71-52698096
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.