Prospective monocenter accuracy study of Vasovist? contrast enhanced magnetic resonance venography (CE-MRV) to detect venous thrombi in patients with Ultrasonography detected peripheral acute deep venous thrombosis (DVT) in at least one vessel
- Conditions
- Acute deep vein thrombosis (DVT)MedDRA version: 9.1Level: LLTClassification code 10051055Term: Deep vein thrombosis
- Registration Number
- EUCTR2007-003762-18-FR
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1. Patients with recent positive DVT by USCD.
2. Patients who have no contra indication to be screened by MRI
3. Patients who have no contra-indication against the IV injection of Vasovist
4. Patients who have given their fully informed and written consent voluntarily.
5. The subject must be covered by a social security system.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Being less than 18 years of age.
2. Having an underlying disease or concomitant medication which may interfere with efficacy or safety evaluations as planned in this study
3. Having any physical or mental status that interferes with the informed consent procedure including self-signed consent.
4. If USCD is performed > 48 hours prior to Vasovist®-MRV.
5. Not being able to remain lying down for at least 45 – 60 min (e.g. patients with unstable angina, dyspnea at rest, severe pain at rest, severe back pain).
6. Presenting with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents.
7. Hypersensitivity to the active substance or to any of the excipients of Vasovist®
8. Being clinically unstable and whose clinical course during the 24 (+ 4) hours observation period is unpredictable.
9. Having any contraindication to MRI examination or specifically for MRV (e.g. pacemaker, recent wound clips, and severe claustrophobia).
10. Renal insufficiency, whatever is the stage.
11. Hepatic insufficiency.
12. The patients having already undergone an injection of Gadolinium.
13. Pregnant women or women breast feeding.
14. Presence of a stent or vascular filter on the examined sites.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the diagnostic value of Vasovist enhanced MRV in terms of accuracy with regard to USCD scanning used as standard of reference (SOR).;Secondary Objective: Evaluate the sensitivity, specificity and accuracy of Vasovist® enhanced MRV with respect to USCD in <br>(1) all 25 segments, <br>(2) the 6 segments below the knee, <br>(3) in 4 segments in the superficial veins, and <br>(4) in the two legs.<br><br>In addition the confidence in diagnosis per segment and the proposed patient management per leg (treatment / no treatment required) will be assessed for both MRV and USCD. <br><br>Safety of Vasovist® enhanced MRV will be assessed in terms of adverse events (AEs) and other safety parameters.<br>;Primary end point(s): - To determine the accuracy of Vasovist® enhanced MRV with respect to ultra sonography duplex coloured scanning as standard of reference (SOR) for the detection/exclusion of deep veinous thrombosis (DVT)
- Secondary Outcome Measures
Name Time Method