|- candidate number||11320|
|- NTR Number||NTR3345|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-mrt-2012|
|- Secondary IDs||2010-197 METC|
|- Public Title||Diffusion MRI; Predictive Value for Cervical Uterine Cancer Recurrence.|
|- Scientific Title||Accuracy of diffusion weighted MRI in detecting residual tumor in patients conservatively treated for cervical carcinoma.|
|- hypothesis||Uterine cervical cancer is the second most common female malignancy. Therapy monitoring is essential to detect early recurrence. Diffusion-weighted magnetic resonance imaging is an emerging MRI imaging technique which has a potential value for the detection of primary and recurrent disease and for the assessment of response to therapy. The purpose of this project is to evaluate the predictive value of DWI during and after therapy in the prediction of recurrence of cervical uterine cancer. It will be considered whether DWI is able to provide early information about the response to therapy. This could enable the identification of less- or non-responsive tumors and in this way therapy can be adapted as soon as possible. Hence the investigators could offer the patient a more efficient treatment scheme and a reduction in toxicity related to the treatment could be established.|
|- Healt Condition(s) or Problem(s) studied||Cervix cancer, MRI, Diffusion weighted imaging (DWI)|
|- Inclusion criteria||1. Primary cervical cancer;|
2. Patients treated with radiation therapy with curative intent, with or without concomitant chemotherapy or hyperthermia;
3. Age ≥ 18 years;
4. Informed consent.
|- Exclusion criteria||1. Pregnancy;|
2. Contra-indications for general anesthesia;
3. Contra-indications for MRI (incl. Claustrophobia, metal implants, renal insufficiency, etc.);
4. Incapacity of judgement.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-apr-2012|
|- planned closingdate||1-apr-2014|
|- Target number of participants||200|
|- Interventions||MRI is a technique based on magnetic fields and do not require the use of ionizing radiation. Because of the strong magnetic field, a few precautions should be taken. This means that all metal and magnetized objects must be removed from the patient before entering the MRI room. Patients with a pacemaker, a cardiac defibrillator or other implanted conductor/prosthesis are for this reason not eligible for the study.
During the examination, an intravenous and vaginal contrast medium will be administered if needed. In most cases, patients do not experience any discomfort and the use of these contrast agents is part of the clinical routine.
|- Primary outcome||The purpose of this project is to evaluate the sensitivity and specificity of DWI after therapy in the prediction of recurrence of cervical uterine cancer.|
|- Secondary outcome||N/A|
|- Timepoints||Endpoint 2014.|
3 measurements: before radiotherapy, before brachytherapy and at the end of the radiotherapy.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Maarten Thomeer|
|- CONTACT for SCIENTIFIC QUERIES|| Maarten Thomeer|
|- Sponsor/Initiator ||Katholieke Universiteit Leuven, Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|Nuts/Ohra, University Hospitals Leuven|
|- Brief summary||Uterine cervical cancer is the second most common female malignancy.
Therapy monitoring is essential to detect residual disease.
Diffusion-weighted(DWI) magnetic resonance imaging (MRI) is an emerging
MRI technique which has a potential value for the detection of residual
disease of cervical cancer after radiotherapy. The purpose of this project
is to evaluate the predictive value of DWI after therapy in the
prediction of residual cervical uterine cancer.Furthermore , it will be
analyzed whether DWI imaging during therapy can predict residual disease.|
|- Main changes (audit trail)|
|- RECORD||12-mrt-2012 - 29-mrt-2012|