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Diffusion MRI; Predictive Value for Cervical Uterine Cancer Recurrence (s52647)

Primary Purpose

Uterine Cervical Cancer, Diffusion-weighted MRI, Recurrence

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Diffusion weighted MRI (DW- MRI)
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Uterine Cervical Cancer focused on measuring Uterine cervical cancer, diffusion-weighted MRI, recurrence

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • University Hospital Gasthuisberg

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Reduction in toxicity related to the treatment
Nowadays, 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.

Full Information

First Posted
October 21, 2010
Last Updated
December 1, 2015
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01226264
Brief Title
Diffusion MRI; Predictive Value for Cervical Uterine Cancer Recurrence
Acronym
s52647
Official Title
Diffusion MRI; Predictive Value for Cervical Uterine Cancer Recurrence.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Cancer, Diffusion-weighted MRI, Recurrence
Keywords
Uterine cervical cancer, diffusion-weighted MRI, recurrence

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Diffusion weighted MRI (DW- MRI)
Intervention 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.
Primary Outcome Measure Information:
Title
Evaluation of the predictive value of DWI during and after therapy in the prediction of recurrence of cervical uterine cancer.
Description
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.
Time Frame
2010-2014 continuously
Secondary Outcome Measure Information:
Title
Reduction in toxicity related to the treatment
Description
Nowadays, 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.
Time Frame
2010-2014

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
University Hospital Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

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Diffusion MRI; Predictive Value for Cervical Uterine Cancer Recurrence

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