NCT01226264|Unknown
Diffusion MRI; Predictive Value for Cervical Uterine Cancer Recurrence
s52647
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s52647
Sponsor study identifier
interventional
40
1 country
1
Study Start
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 21, 2010
Actual (reported)October 22, 2010
Actual (reported)November 2010
Date type not reportedThis date has not been verified as actual or estimated.
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Reduction in toxicity related to the treatment
2010-2014
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.
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University Hospital Gasthuisberg
Leuven, Leuven, 3000, Belgium
First Submitted
October 21, 2010
First Posted
October 22, 2010
Study Start
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2015
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 2, 2015
Record last verified: 2015-12
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Source: ClinicalTrials.gov.
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