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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2011 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
katrijn Michielsen, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01226264
First received: October 21, 2010
Last updated: September 27, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Uterine Cervical Cancer
Diffusion-weighted MRI
Recurrence
Procedure: Diffusion weighted MRI (DW- MRI)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Diffusion MRI; Predictive Value for Cervical Uterine Cancer Recurrence.

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2010-2014 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: November 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Diffusion 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01226264

Contacts
Contact: Ilse Roebben, Master in Biomedical Sciences +32 16 34 90 74 ilse.roebben@uzleuven.be
Contact: Katrijn Michielsen, Master in Biomedical Sciences +32 16 34 90 76 katrijn.michielsen@uzleuven.be

Locations
Belgium
University Hospital Gasthuisberg Recruiting
Leuven, Belgium, 3000
Principal Investigator: Vincent Vandecaveye, MD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: katrijn Michielsen, PhD researcher Radiology, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01226264     History of Changes
Other Study ID Numbers: s52647
Study First Received: October 21, 2010
Last Updated: September 27, 2011
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
Uterine cervical cancer
diffusion-weighted MRI
recurrence

Additional relevant MeSH terms:
Uterine Neoplasms
Body Weight
Uterine Cervical Neoplasms
Recurrence
Signs and Symptoms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014