E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
endometriosis |
endometriose |
|
E.1.1.1 | Medical condition in easily understood language |
endometriosis |
endometriose |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
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 |
test the feasibility to diagnose endometriosis using MRI and ablavar |
het testen van de haalbaarheid van endometriose met MRI, en ablavar diagnose |
|
E.2.2 | Secondary objectives of the trial |
assess the quality of the imaging |
beoordeel de kwaliteit van de beeldvorming |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
18 years and older; Suspicion of peritoneal endometriosis, palpable nodule located at the sacrouterine ligaments at physical examination; Patient planned for MRI and laparoscopic diagnosis and treatment of the disease (care as usual); Pre menopausal; Using contraception during the time of the study; Willing and able to undergo all study procedures; Written informed consent.
|
18 jaar en ouder; Vermoeden van peritoneale endometriose, voelbaar knobbeltje gelegen aan de sacrouterine ligamenten te lichamelijk onderzoek; Patiënt gepland voor MRI en laparoscopische diagnose en behandeling van de ziekte (gebruikelijke zorg); Pre menopauze; In gebruik van anticonceptie; Bereid en in staat om alle studie-procedures ondergaan; Schriftelijk toestemming. |
|
E.4 | Principal exclusion criteria |
Pregnancy / breast feeding; Post menopausal or under GnRH analogue treatment; Patients presenting with a contraindication to MRI such as pacemaker, aneurysm clip, severe claustrophobia or ferromagnetic implants; Impaired kidney function or acute kidney injury; History of severe allergic reaction or allergic reaction to MR contrast media; Allergy (hypersensitivity) to any of the ingredients of Ablavar ®; Being unable to give informed consent in person.
|
Zwangerschap / borstvoeding; Post-menopauzale status of onder GnRH analoog behandeling; Patiënten met een contra-indicatie voor MRI, zoals een pacemaker, aneurysmaclip, ernstige claustrofobie of ferromagnetische implantaten; Verminderde nierfunctie of acute nierschade; De geschiedenis van ernstige allergische reactie of een allergische reactie op MR contrastmiddelen; Allergie (overgevoeligheid) voor een van de bestanddelen van Ablavar ®; Niet in staat om geïnformeerde toestemming te geven in eigen persoon.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
non applicable |
niet van toepassing |
|
E.5.2 | Secondary end point(s) |
non applicable |
niet van toepassing |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
non applicable |
niet van toepassing |
|
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 | 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) | 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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
|
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.8.5 | 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 | No |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |