on-invasive diagnosis of endometriosis
- Conditions
- endometriosisTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2012-002991-15-NL
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): non applicable;Timepoint(s) of evaluation of this end point: non applicable