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


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Open (Enrolling)
Female
Ovarian Carcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Outcome Measure:

Validation of interpretation criteria of WB-DWI for staging and thresholding for treatment assessment in pilot study

Outcome Description:

Validation of interpretation criteria of WB-DWI for staging and thresholding for treatment assessment in pilot study

Outcome Time Frame:

Nov 2011 - Sep 2012 (up to 1 year)

Safety Issue:

No

Principal Investigator

Vincent Vandecaveye, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UZ Leuven

Authority:

Belgium: Ethics Committee

Study ID:

S53580

NCT ID:

NCT01657747

Start Date:

November 2011

Completion Date:

August 2016

Related Keywords:

  • Ovarian Carcinoma
  • Ovarian carcinoma
  • Staging
  • Early treatment follow-up
  • Identifying tumor recurrence
  • Whole body diffusion-weighted MRI
  • Carcinoma
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Recurrence

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