Whole-body Diffusion MRI for Staging, Response Prediction and Detecting Tumor Recurrence in Patients With Ovarian Cancer (S53580)
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 Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
|Official Title:||Whole-body Diffusion MRI for Staging, Response Prediction and Detecting Tumor Recurrence in Patients With Ovarian Cancer|
- 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) ] [ Designated as safety issue: No ]Validation of interpretation criteria of WB-DWI for staging and thresholding for treatment assessment in pilot study
- WB-DWI for tumor characterization and staging at primary diagnosis [ Time Frame: Nov 2011 - Nov 2015 (expected) (up to 4 years) ] [ Designated as safety issue: No ]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.
- WB-DWI for response assessment during and early after neoadjuvant chemotherapy [ Time Frame: Nov 2011 - Nov 2015 (expected) (up to 4 years) ] [ Designated as safety issue: No ]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
- The prognostic value of DWI-determined imaging markers [ Time Frame: Nov 2013 - Nov 2015 (expected) (up to 2 years) ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657747
|Contact: Katrijn Michielsen, Master in Biomedical Sciences||+32 16 34 90 firstname.lastname@example.org|
|Contact: Ilse Roebben, Master in Biomedical Sciences||+32 16 34 90 email@example.com|
|University Hospitals UZ Leuven, Gasthuisberg||Recruiting|
|Leuven, Belgium, 3000|
|Contact: Vincent Vandecaveye, MD, PhD +32 16 34 05 18 firstname.lastname@example.org|
|Contact: Katrijn Michielsen, Master in Biomedical Sciences +32 16 34 90 76 email@example.com|
|Principal Investigator: Vincent Vandecaveye, MD, PhD|
|Principal Investigator:||Vincent Vandecaveye, MD, PhD||UZ Leuven|