search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Diffusion MRI; Predictive Value for Cervical Uterine Cancer Recurrence.


- candidate number11320
- NTR NumberNTR3345
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-mrt-2012
- Secondary IDs2010-197 METC
- Public TitleDiffusion MRI; Predictive Value for Cervical Uterine Cancer Recurrence.
- Scientific TitleAccuracy of diffusion weighted MRI in detecting residual tumor in patients conservatively treated for cervical carcinoma.
- ACRONYM
- hypothesisUterine 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) studiedCervix cancer, MRI, Diffusion weighted imaging (DWI)
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-apr-2012
- planned closingdate1-apr-2014
- Target number of participants200
- InterventionsMRI 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 outcomeThe 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 outcomeN/A
- TimepointsEndpoint 2014.
3 measurements: before radiotherapy, before brachytherapy and at the end of the radiotherapy.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Maarten Thomeer
- CONTACT for SCIENTIFIC QUERIES Maarten Thomeer
- Sponsor/Initiator Katholieke Universiteit Leuven, Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Nuts/Ohra, University Hospitals Leuven
- PublicationsN/A
- Brief summaryUterine 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)
- RECORD12-mrt-2012 - 29-mrt-2012


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl