Diagnosis of endometriosis using Magnetic Resonance Imaging.|
|- candidate number||14064|
|- NTR Number||NTR3738|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-dec-2012|
|- Secondary IDs||41273 ABR|
|- Public Title||Diagnosis of endometriosis using Magnetic Resonance Imaging.|
|- Scientific Title||Magnetic Resonance Imaging to diagnose endometriosis using Ablavar ®
as contrast agent: A feasibility study.|
|- ACRONYM||Ablavar ® in endometriosis diagnosis|
|- hypothesis||Dynamic-CE-MRI using Ablavar ® can efficiently visualise endometriosis associated angiogenesis.|
|- Healt Condition(s) or Problem(s) studied||Endometriosis, Magnetic resonance imaging (MRI) , Diagnosis, Angiogenesis, Gadofosveset|
|- 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||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.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-feb-2013|
|- planned closingdate||1-apr-2013|
|- Target number of participants||5|
|- 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 who are planned for laparoscopy (for diagnosis and treatment) will be subject to an extra MRI suing godofosveset (Ablavar) and contrast agent (intervention). |
|- Primary outcome||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||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.
|- Timepoints||1. Physical examination, surgical/medical history;|
2. MRI investigation;
3. Within two weeks from '2', laparoscopy;
4. Data analyses.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. Andrea Romano|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Andrea Romano|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|Maastricht Universitair Medisch Centrum (MUMC+)|
|- Publications||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.
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
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.
|- Brief summary||Rationale: |
Endometriosis is defined as the presence of functional endometrium outside the uterus and affects 10-15% of women during pre-menopause. Endometriosis is diagnosed by means of an invasive diagnostic test, i.e. a laparoscopy. Since symptoms are common to other disturbances, and there is no non-invasive diagnostic test, there is a delay in diagnosing the disease up to 8-11 years. Therefore, the development of a non-invasive diagnostic test for endometriosis is needed.
Endometriosis is characterised by abundant angiogenesis. Based on experience in oncology and based on preclinical studies using a mouse-model of endometriosis, endometriosis-associated angiogenesis can be visualised by contrast enhanced magnetic resonance imaging (CE-MRI) using gadovosveset-trsodium (drug name Ablavar ®, marketed by Lantheus Medical Imaging).
Test the feasibility of Dynamic-CE-MRI using Ablavar ® as contrast agent to detect endometriosis is women.
Feasibility, open label study.
N = 5 premenopausal women (≥ 18 years), with a suspicion of endometriosis, undergoing a laparoscopy to diagnose and surgically treat endometriosis.
Before laparoscopy, patients will be subjected to standard and CE MRI suing Ablavar ® as contrast agent.
Main study parameters/endpoints:
Feasibility of Ablavar ® - enhanced MRI for detection of superficial endometriosis using histology as the diagnostic gold standard.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Beside routine procedures for endometriosis treatment (MRI and laparoscopy) the patient will receive an additional MR protocol using Ablavar ® to enhance image contrast. The use of Ablavar ® is safe in human. Some common reaction to it can be headache, nausea, pruritus, cold feeling.
|- Main changes (audit trail)|
|- RECORD||5-dec-2012 - 19-dec-2012|
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