Diffusion MRI; Predictive Value for Cervical Uterine Cancer Recurrence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2016-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Uterine Cervical Cancer Diffusion-weighted MRI Recurrence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

katrijn Michielsen

PhD researcher Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Gasthuisberg

Leuven, Leuven, Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

s52647

Identifier Type: -

Identifier Source: org_study_id