Clinical impact of dedicated MR staging of ovarian cancer patients

Recruiting

Conditions: Peritoneal Carcinomatosis
Peritoneal Seeding
10038594

Registration Number: NL-OMON48584

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 270

Inclusion Criteria

- Patients with advanced stage (FIGO stage III or IV) ovarian cancer scheduled for primary or interval cytoreductive surgery
- Age >18 years
- Written informed consent

Exclusion Criteria

Patients with contraindications for MRI:
- Patients who have a heart pacemaker may not have an MRI scan
- Patients who have a metallic foreign body (metal sliver) in their body
- Patients with severe claustrophobia
- Contrast allergy for MRI contrast agent Gadolinium (extremely rare)
- Ineligibility to receive gadofosveset contrast (history of contrast allergy, impaired kidney function with a Glomerular Filtration Rate <30 ml/min/1.73m2)
- Ineligibility to receive Buscopan
- Allergy for pineapple juice and blueberry juice.
Patients with contraindications for CRS
- WHO performance status 3 or higher

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Diagnostic performance of DW-MRI to predict whether complete cytoreductive<br /><br>surgery can be achieved (defined as the number of cytoreductive procedures<br /><br>correctly predicted by DW-DWI).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Diagnostic performance of radiological Peritoneal Cancer Index (rPCI)<br /><br>determined DW-MRI to predict surgical Peritoneal Cancer Index (sPCI).<br /><br>- Inter-observer agreement between different readers for DW-MRI.<br /><br>- Diagnostic performance of radiological Peritoneal Cancer Index (rPCI)<br /><br>determined CT to predict surgical Peritoneal Cancer Index (sPCI).<br /><br>- Comparing the performance of CT and MRI.<br /><br>- Number of additional second look surgical findings due to the per-operative<br /><br>availability of DW-MRI findings<br /><br>- Incremental costs, effects, and incremental cost-effectiveness ratio</p><br>