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Trial Title:
Diffusion MRI; Predictive Value for Cervical Uterine Cancer Recurrence
NCT ID:
NCT01226264
Condition:
Uterine Cervical Cancer
Diffusion-weighted MRI
Recurrence
Conditions: Official terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Recurrence
Body Weight
Conditions: Keywords:
Uterine cervical cancer
diffusion-weighted MRI
recurrence
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Diffusion weighted MRI (DW- MRI)
Description:
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.
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.
Criteria for 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).
Gender:
Female
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Gasthuisberg
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Start date:
November 2010
Completion date:
April 2016
Lead sponsor:
Agency:
Universitaire Ziekenhuizen KU Leuven
Agency class:
Other
Source:
Universitaire Ziekenhuizen KU Leuven
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01226264
