Clinical trial NCT01657747: Whole-body Diffusion MRI for Staging, Response Prediction and Detecting Tumor Recurrence in Patients With Ovarian Cancer
Official title: Whole-body Diffusion MRI for Staging, Response Prediction and Detecting Tumor Recurrence in Patients With Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Carcinoma
Keywords: Ovarian carcinoma
Staging
Early treatment follow-up
Identifying tumor recurrence
Whole body diffusion-weighted MRI
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-08-06
Enrollment: 350
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Validation of interpretation criteria of WB-DWI for staging and thresholding for treatment assessment in pilot study
timeFrame: Nov 2011 - Sep 2012 (up to 1 year)
measure: WB-DWI for tumor characterization and staging at primary diagnosis
timeFrame: Nov 2011 - Nov 2015 (expected) (up to 4 years)
measure: WB-DWI for response assessment during and early after neoadjuvant chemotherapy
timeFrame: Nov 2011 - Nov 2015 (expected) (up to 4 years)
Secondary outcomes:
measure: The prognostic value of DWI-determined imaging markers
timeFrame: Nov 2013 - Nov 2015 (expected) (up to 2 years)
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals UZ Leuven, Gasthuisberg
Study officials:
affiliation: UZ Leuven
name: Vincent Vandecaveye, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: