MR-imaging to diagnose endometriosis using Ablavar ® as contrast agent – a feasibility study’

Not provided0 sitesOctober 19, 2012

Overview

No summary available.

Registry

who.int

Start Date

October 19, 2012

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

Not provided

•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

•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.