E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Abnormalities of the major venous system. |
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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 | 10047184 |
E.1.2 | Term | Vein disorder |
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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 assess image quality in terms of vessel conspicuity using a five-point scale - excellent (optimal visualisation of the vessel with no signal loss), good (slight signal loss but good overall visualisation of the vessel), moderate (decreased signal intensity but images remain diagnostic), poor (insufficient signal intensity such that the vessel is not completely identifiable and the image is not diagnostic, or very poor (no or hardly any signal intensity and the vessel cannot be identified). |
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E.2.2 | Secondary objectives of the trial |
To assess for stenosis using a six-point scale – no (0%) stenosis, mild (1-30%) stenosis, mild-to-moderate (31-50%) stenosis, moderate (51-75%) stenosis, severe (76-99%) stenosis, or total vessel occlusion. To assess for additional thrombosis using a three-point scale – no thrombosis, partial thrombosis, complete thrombosis. To assess for the presence of artifacts as rated by a three-point scale – none, mild (artifacts present but not impairing diagnostic information), or major (extensive artifacts impair diagnosis).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients over 18 years of age who have been routinely referred for an MR angiography examination to assess the major thoraco-abdominal veins (including in the neck) in respect of venous access. |
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E.4 | Principal exclusion criteria |
The presence of any of the following will preclude patient inclusion:
- Age of the patient under 18 years. - Contraindication to MRI (eg. Pacemaker, aneurysm clips, orbital metal) - Contraindication to intravenous gadolinium agents (eg. Contrast medium allergy). In Addenbrooke’s Hospital, this includes patients with liver transplants and patients with impaired renal function (GFR of less than 60 ml/min/1.73 m2) - Pregnant or lactating women. |
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E.5 End points |
E.5.1 | Primary end point(s) |
After completion of 30 MR angiography studies assessing the venous system. |
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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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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) | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
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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After completion of 30 MR angiography studies assessing the venous system. |
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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 | |
E.8.9.1 | In the Member State concerned days | |