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

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Conditions

Ovarian Carcinoma

Treatments

Other: Whole body diffusion-weighted MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT01657747

S53580

Details and patient eligibility

About

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

Full description

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.

Enrollment

350 patients

Sex

Female

Volunteers

No Healthy Volunteers

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