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Diffusion MRI; Predictive Value for Cervical Uterine Cancer Recurrence

Diffusion MRI; Predictive Value for Cervical Uterine Cancer Recurrence.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01226264
Acronym
s52647
Enrollment
40
Registered
2010-10-22
Start date
2010-11-30
Completion date
2016-04-30
Last updated
2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffusion-weighted MRI, Recurrence, Uterine Cervical Cancer

Keywords

Uterine cervical cancer, diffusion-weighted MRI, recurrence

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.

Interventions

PROCEDUREDiffusion 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.

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the predictive value of DWI during and after therapy in the prediction of recurrence of cervical uterine cancer.2010-2014 continuouslyThe 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

MeasureTime frameDescription
Reduction in toxicity related to the treatment2010-2014Nowadays, 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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026