Whole-body Diffusion MRI for Staging, Response Prediction and Detecting Tumor Recurrence in Patients With Ovarian Cancer (S53580)

July 1, 2015 updated by: Universitaire Ziekenhuizen KU Leuven

The aim of this study is to assess whole body diffusion weighted imaging (WB-DWI) as a non-invasive method for

  • accurate staging of patient suspected having ovarian cancer
  • early treatment assessment
  • detecting tumor recurrence

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Staging --- (PET-)CT is used nowadays to provide imaging information about the disease burden of ovarian cancer patients and a diagnostic staging laparoscopy under general anesthesia is often necessary to allow correct and accurate staging. The applicant propose an "all-in-one" imaging modality providing high quality thoracic-abdominal images without using ionizing radiation and/or radioactive material. This allows accurate assessment of operability in a minimally invasive manner.
  2. Early treatment assessment --- Although response to the first administration of chemotherapy is quite reasonable, most patients show tumor recurrence and achieve increasingly poorer response rates to second- or third-line regimes. Therefore it is of major concern that a individualized prediction of chemosensitivity can be performed avoiding unnecessary toxicity from inefficient chemotherapeutic agents. A promising perspective is that the predictive data to be generated might prove to be sufficiently powerful to predict chemosensitivity early in the course of the treatment, facilitating a timely change of treatment in nonresponders. This could avoid unnecessary toxicity for patients, improving quality of life and moreover implicate considerable savings for the healthcare sector.
  3. Identifying tumor recurrence --- Identifying tumor recurrence at an early stage could translate into reduction of unnecessary biopsies, cost savings and reduced morbidity associated with the biopsy procedure. But the most important issue is that early diagnosis can be life saving with respect to tumor recurrence.

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • University Hospitals UZ Leuven, Gasthuisberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • STAGING: patients with suspected ovarian carcinoma
  • EARLY TREATMENT ASSESSMENT: patients with FIGO stage IIIc or IV ovarian carcinoma who will undergo neoadjuvant chemotherapy
  • IDENTIFYING TUMOR RECURRENCE: patients with a medical history of ovarian carcinoma with suspicion of recurrent ovarian cancer after a disease-free-interval of at least 6 months

Exclusion Criteria:

  • patients with known contra-indications for MRI (cardiac pacemakers, cochlear implants, claustrophobic patients)will be excluded from this study.
  • patients with contra-indications to gadolinium-based contrast agents (including patients with a known restricted renal function; GFR < 30 mL/min)and/or Buscopan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Not applicable (imaging study)
Other: Whole body diffusion-weighted MRI

MRI is a technique based on magnetic fields and does not require the use of ionizing radiation. Although there are no known side effects associated with MRI, a few precautions should be taken because of the 3T magnetic field. This implicates 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 conductors/prostheses are for this reason not eligible for the study.

During the whole body MRI examination, an intravenous contrast agent will be administered. In most cases, patients do not experience any discomfort and the use of this contrast agent is part of the clinical routine.

During the whole body MRI examinations, a bowel relaxing injection (Buscopan) is also needed to reduce movement of the intestines.

Other Names:
  • Dotarem
  • Buscopan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of interpretation criteria of WB-DWI for staging and thresholding for treatment assessment in pilot study
Time Frame: Nov 2011 - Sep 2012 (up to 1 year)
Validation of interpretation criteria of WB-DWI for staging and thresholding for treatment assessment in pilot study
Nov 2011 - Sep 2012 (up to 1 year)
WB-DWI for tumor characterization and staging at primary diagnosis
Time Frame: Nov 2011 - Nov 2015 (expected) (up to 4 years)
The aim of this part of the study is to prospectively evaluate WB-DWI for tumor characterization and staging at primary diagnosis in comparison to CT and combined CT/diagnostic laparoscopy with the aim to assess patient operability.
Nov 2011 - Nov 2015 (expected) (up to 4 years)
WB-DWI for response assessment during and early after neoadjuvant chemotherapy
Time Frame: Nov 2011 - Nov 2015 (expected) (up to 4 years)
The aim of this part of the study is to prospectively evaluate WB-DWI for (early) response assessment during and early after neoadjuvant chemotherapy in comparison to CT with the aim to predict chemotherapy induced tumor load regression and subsequent operability
Nov 2011 - Nov 2015 (expected) (up to 4 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prognostic value of DWI-determined imaging markers
Time Frame: Nov 2013 - Nov 2015 (expected) (up to 2 years)
The aim of this part of the study is the determination of prognostic DWI-determined imaging and response markers towards patients disease free survival and overall survival.
Nov 2013 - Nov 2015 (expected) (up to 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Vincent Vandecaveye, MD, PhD, UZ Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

November 2, 2011

First Submitted That Met QC Criteria

August 3, 2012

First Posted (ESTIMATE)

August 6, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 2, 2015

Last Update Submitted That Met QC Criteria

July 1, 2015

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S53580

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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