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Search / Trial NCT06390475

Optimizing Diagnosis of Splanchic Vein Thrombosis With MRDTI (Rhea)

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Apr 25, 2024

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Mr Direct Thrombus Imaging Splanchnic Vein Thrombosis Diagnostic Management

ClinConnect Summary

The Rhea study is a clinical trial designed to improve the way doctors diagnose a condition called Splanchnic Vein Thrombosis (SVT), which is a type of blood clot that can occur in veins in the abdomen. Researchers are testing a new imaging technique called MRDTI, which has shown promise in accurately identifying blood clots in other areas of the body. This study aims to find out if MRDTI can help determine the age of the clot in patients who have been diagnosed with incidental SVT, meaning the clots were found by chance and may not be causing any symptoms. Understanding the age of the clot is important because it can help doctors decide whether patients need treatment with blood thinners.

To participate in this trial, you must be at least 18 years old and either have confirmed acute SVT or have chronic SVT that isn't causing symptoms. However, there are some reasons you might not be eligible, such as having certain medical devices that make MRI scans unsafe or having serious medical conditions that could interfere with the study. If you join the study, you'll undergo an MRI scan and be monitored for 90 days to see how well the MRDTI technique works in diagnosing SVT and guiding treatment decisions. This trial is currently recruiting participants and could lead to better, more personalized care for patients with this condition.

Gender

ALL

Eligibility 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

About Leiden University Medical Center

Leiden University Medical Center (LUMC) is a prominent academic medical center located in the Netherlands, renowned for its commitment to advancing healthcare through innovative research and high-quality patient care. As a clinical trial sponsor, LUMC focuses on translating scientific discoveries into effective therapies, fostering collaborations between researchers, clinicians, and industry partners. The center is dedicated to conducting rigorous clinical studies across various medical fields, ensuring adherence to ethical standards and regulatory requirements while prioritizing patient safety and outcomes. Through its multidisciplinary approach, LUMC aims to contribute significantly to the understanding and treatment of complex health conditions, driving progress in personalized medicine and improving global health.

Locations

Rotterdam, , Netherlands

Varese, , Italy

Rome, , Italy

Patients applied

0 patients applied

Trial Officials

F.A. Klok, Prof.

Principal Investigator

Study Principal Investigator

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported