endometriosis
Conditions
Interventions
Trade Name: ablavar
Product Name: gadofosveset-trisodium
Product Code: not applicable
Pharmaceutical Form: Solution for injection
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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 5 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: test the feasibility to diagnose endometriosis using MRI and ablavar ;Secondary Objective: assess the quality of the imaging;Primary end point(s): Laparoscopy;Timepoint(s) of evaluation of this end point: non applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): non applicable;Timepoint(s) of evaluation of this end point: non applicable | — |
Countries
Netherlands
Outcome results
None listed