This trial is active, not recruiting.

Conditions uterine cervical cancer, diffusion-weighted mri, recurrence
Treatment diffusion weighted mri (dw- mri)
Sponsor Universitaire Ziekenhuizen Leuven
Start date November 2010
End date December 2015
Trial size 40 participants
Trial identifier NCT01226264, s52647


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic

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

Secondary Outcomes

Reduction in toxicity related to the treatment
time frame: 2010-2014

Eligibility Criteria

Female participants of any age.

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).

Additional Information

Official title Diffusion MRI; Predictive Value for Cervical Uterine Cancer Recurrence.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Universitaire Ziekenhuizen Leuven.