Diagnosis of endometriosis using Magnetic Resonance Imaging.

• Conditions: EndometriosisMagnetic Resonance ImagingGadofosvesetAngiogenesisDiagnosis

• Registration Number: NL-OMON25187
• Lead Sponsor: Maastricht University Medical Centre

Brief Summary

Schreinemacher, M.H., W.H. Backes, J.M. Slenter, S. Xanthoulea, B. Delvoux, L. van Winden, R.G. Beets-Tan, J.L. Evers, G.A. Dunselman, and A. Romano, Towards endometriosis diagnosis by gadofosveset-trisodium enhanced magnetic resonance imaging. PLoS One, 2012. 7(3): p. e33241. <br><br> de Lussanet, Q.G., J.C. van Golde, R.G. Beets-Tan, M.J. Post, M.S. Huijberts, N.C. Schaper, A.G. Kessels, J.M. van Engelshoven, and W.H. Backes, Dynamic contrast-enhanced MRI of muscle perfusion combined with MR angiography of collateral artery growth in a femoral artery ligation model. NMR Biomed, 2007. 20(8): p. 717-25 <br><br> McGregor, R., J. Vymazal, M. Martinez-Lopez, J. Neuwirth, P. Salgado, JP. Beregi, E. de la Pena-Almaguer, GJ. Slater, K. Shamsi and EC. Parsons EC Jr., A multi-center, comparative, phase 3 study to determine the efficacy of gadofosveset-enhanced magnetic resonance angiography for evaluation of renal artery disease. Eur J Radiol, 2008. 65(2): p. 316-25.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 5

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;

Exclusion Criteria

1. Pregnancy / breast feeding;

2. Post menopausal or under GnRH analogue treatment;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Total number of endometriosis implants in unenhanced MRI and Ablavar ® -enhanced MRI;<br /><br>2. Total number of images with good / moderate / poor image quality of unenhanced MRI and Ablavar ® -enhanced MRI;<br /><br>3. Occurrence of AEs.