E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute deep vein thrombosis (DVT) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051055 |
E.1.2 | Term | Deep vein thrombosis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate the diagnostic value of Vasovist enhanced MRV in terms of accuracy with regard to USCD scanning used as standard of reference (SOR). |
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E.2.2 | Secondary objectives of the trial |
Evaluate the sensitivity, specificity and accuracy of Vasovist® enhanced MRV with respect to USCD in (1) all 25 segments, (2) the 6 segments below the knee, (3) in 4 segments in the superficial veins, and (4) in the two legs.
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.
Safety of Vasovist® enhanced MRV will be assessed in terms of adverse events (AEs) and other safety parameters.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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. |
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E.4 | Principal exclusion criteria |
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.
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E.5 End points |
E.5.1 | 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) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |