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Clinical Trials/NCT01226264
NCT01226264
Unknown
Not Applicable

Diffusion MRI; Predictive Value for Cervical Uterine Cancer Recurrence.

Universitaire Ziekenhuizen KU Leuven1 site in 1 country40 target enrollmentNovember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Uterine Cervical Cancer
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
40
Locations
1
Primary Endpoint
Evaluation of the predictive value of DWI during and after therapy in the prediction of recurrence of cervical uterine cancer.
Last Updated
10 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
April 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

katrijn Michielsen

PhD researcher Radiology

Universitaire Ziekenhuizen KU Leuven

Eligibility Criteria

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).

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Reduction in toxicity related to the treatment(2010-2014)

Study Sites (1)

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