E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with low or moderate clinical probability for pulmonary embolism and positive or negative CTA for pulmonary embolism after CT and sonographic examination for deep venous thrombosis. |
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MedDRA Classification |
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 assess the feasibility and accuracy of comprehensive whole-body 3T MRA of patients with low or moderate clinical probability for pulmonary embolism using an intravascular MR contrast agent (Vasovist®) for detection of pulmonary embolism and underlying deep venous thrombosis in a single examination. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with low or moderate clinical probability for pulmonary embolism (Wells score, see appendix 1) and positive or negative CTA for pulmonary embolism.
Patients who are willing to undergo MRA with Vasovist® -after getting a detailed information about the treatment by an (co)investigator- and will give their signed informed consent form. The distribution of gender is irrelevant. The patient group reflects the clinic's average.
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E.4 | Principal exclusion criteria |
Less than 18 years of age. Women who are pregnant, lactating or who are of childbearing potential and have not had a negative urine pregnancy test the same days as administration of Vasovist®. The manufacturer’s instructions for performing the urinary pregnancy test are to be followed. People with proven central pulmonary embolism (main left or right pulmonary artery) Known underlying pulmonary disease: e.g. lung cancer, chronic obstructive pulmonary disease Having an underlying disease or concomitant medication (or are scheduled for any therapy) which may interfere with efficacy or safety evaluations as planned in this study Having any physical or mental status that interferes with the informed consent procedure incl. self-signed consent. Having a history of alcohol or drug abuse or dependency. Having received any investigational drug within 30 days prior to entering this study or who are planned to receive any other investigational drug during the 24 (+ 4) hours safety follow-up period. 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). Presenting with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents. Presenting sickle cell disease or other hemolytic anemia. Being clinically unstable Being scheduled for, or likely to require, any surgical intervention within 24 hours before or within the follow-up period. Having any contraindication to MRI examination or specifically for MRA (e.g. pacemaker, recent wound clips, and severe claustrophobia). High clinical probability for PE Patient who have received Gadolinum within 24 hours prior to Vasovist® injection. Patients with impaired renal function as indicated by CreatininClearance below 30ml/min (MDRD/Cockroft-Gault) (laboratory diagnostic data required) Patients with impaired liver function (laboratory diagnostic data required)
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E.5 End points |
E.5.1 | Primary end point(s) |
Feasibility: number technically successful MRI exams. A successful exam is defined as a completed imaging protocol (First-pass MRA (perfusion MRI), steady-state MRA, MR venography) with diagnostic image quality (as determined by the blinded reading) Accuracy: Accuracy (sensitivity, specificity, accuracy, PPV, NPV) of MRI for the detection of pulmonary embolism and venous thrombosis compared to the gold standard (CTA and venous ultrasound) Total imaging time of MRI (First-pass MRA (perfusion MRI), steady-state MRA, MR venography). Subjective image quality of MRI (1=non-diagnostic, 2=poor, 3=moderate, 4=good, 5=excellent).
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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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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 | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 |