Diffusion MRI; Predictive Value for Cervical Uterine Cancer Recurrence

Study Overview
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Brief Summary
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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.

Official Title
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Diffusion MRI; Predictive Value for Cervical Uterine Cancer Recurrence.

Conditions
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Uterine Cervical Cancer, Diffusion-weighted MRI, Recurrence

Intervention / Treatment
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* Procedure: Diffusion weighted MRI (DW- MRI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with cervical uterine cancer are, on a voluntary basis, enrolled in the study. These are patients who either underwent curative chemoradiation (mainly patients with advanced stage cancer) or neoadjuvant chemotherapy (predominantly in patients with early stage cancer) before undergoing surgery. Exclusion Criteria: Patients with known contra-indications for MRI (cardiac pacemakers, cochlear implants, claustrophobic patients) will be excluded from this study. And so are patients with contra-indications to Gadolinium-based contrast agents and patients with a known restricted renal function (GFR < 30 ml/min).
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the predictive value of DWI during and after therapy in the prediction of recurrence of cervical uterine cancer. | 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. | 2010-2014 continuously | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in toxicity related to the treatment | 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. | 2010-2014 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine cervical cancer, diffusion-weighted MRI, recurrence