Diagnosis of endometriosis using Magnetic Resonance Imaging.

Magnetic Resonance Imaging to diagnose endometriosis using Ablavar ® as contrast agent: A feasibility study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25187

Enrollment

Registered

2012-12-05

Start date

2013-02-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis Magnetic Resonance Imaging Gadofosveset Angiogenesis Diagnosis

Interventions

Women presenting at the gynaecological outpatient department with suspicion of endometriosis based on positive findings during physical examination (palpable nodule of the uterosacral ligaments) and w

Eligibility

Inclusion criteria

Inclusion criteria: 1. 18 years and older; 2. Suspicion of (peritoneal) endometriosis, palpable nodule located at the sacrouterine ligaments based on history and/or physical examination; 3. Patient planned for MRI and laparoscopic diagnosis and treatment of the disease (care as usual); 4. Pre menopausal; 5. Using contraception during the time of the study; 6. Willing and able to undergo all study procedures; 7. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnancy / breast feeding; 2. Post menopausal or under GnRH analogue treatment; 3. Patients presenting with a contraindication to MRI such as pacemaker, aneurysm clip, severe claustrophobia or ferromagnetic implants; 4. Impaired kidney function (estimated Glomerular Filtration Rate, eGFR < 60) or acute kidney injury; 5. History of severe allergic reaction or allergic reaction to MR contrast media; 6. Allergy (hypersensitivity) to any of the ingredients of Ablavar ®; 7. Being unable to give informed consent in person.

Design outcomes

Primary

Measure	Time frame
Feasibility of Ablavar ® - enhanced MRI for detection of peritoneal endometriosis using histology as the diagnostic standard of reference. For the present study, the findings of the MRI will be compared with the diagnosis of peritoneal endometriosis by laparoscopy; the MRI will indicate if and where peritoneal endometriosis will be found, this will be compared by the results of the laparoscopy.	—

Secondary

Measure	Time frame
1. Total number of endometriosis implants in unenhanced MRI and Ablavar ® -enhanced MRI; 2. Total number of images with good / moderate / poor image quality of unenhanced MRI and Ablavar ® -enhanced MRI; 3. Occurrence of AEs.	—

Contacts

Public ContactAndrea Romano

Dept. Obstetrics and Gynaecology GROW-School for Oncology and Developmental Biology Maastricht University Medical Centre P. Debyelaan 25

a.romano@maastrichtuniversity.nl+31 (0)43 3881286

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)