Diffusion MRI; Predictive Value for Cervical Uterine Cancer Recurrence (s52647)
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|ClinicalTrials.gov Identifier: NCT01226264|
Recruitment Status : Unknown
Verified December 2015 by katrijn Michielsen, Universitaire Ziekenhuizen Leuven.
Recruitment status was: Active, not recruiting
First Posted : October 22, 2010
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Uterine Cervical Cancer Diffusion-weighted MRI Recurrence||Procedure: Diffusion weighted MRI (DW- MRI)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diffusion MRI; Predictive Value for Cervical Uterine Cancer Recurrence.|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||April 2016|
- Procedure: Diffusion weighted MRI (DW- MRI)
An MRI examination (including diffusion-weighted sequences) belongs to the standard protocol for patients with cervical uterine cancer. The additional burden is therefore restricted to an extra MRI scan during and/or early after therapy.
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. In most cases, patients do not experience any discomfort and the use of these contrast agents is part of the clinical routine.
- Evaluation of the predictive value of DWI during and after therapy in the prediction of recurrence of cervical uterine cancer. [ Time Frame: 2010-2014 continuously ]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.Several studies and a significant experience of our research groups have shown an advantage of DWI for early detection of cancer and evaluation of therapeutic effects [7-10]. This has not yet been demonstrated in patients with cervical uterine cancer. This study aims to expand the scope of the use of DWI.
- Reduction in toxicity related to the treatment [ Time Frame: 2010-2014 ]Nowadays, a large amount of possible treatment schemes for cervical uterine cancer are available but there is an increased need for early and non-invasive treatment follow-up. This could enable the identification of less- or non-responsive tumors and in this way therapy can be adapted as soon as possible. Hence we could offer the patient a more efficient treatment scheme and a reduction in toxicity related to the treatment could be established.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01226264
|University Hospital Gasthuisberg|
|Leuven, Belgium, 3000|