Dedicated MR imaging vs surgical staging of peritoneal carcinomatosis in colorectal cancer patients; a randomized multicenter trial

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 192

Inclusion Criteria

- Patients with suspicion of colorectal peritoneal metastases and considered
for CRS/HIPEC
- Age >18 years
- Written and signed informed consent
- WHO 0-2
- Able and willing to drink 1 liter of pineapple juice

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
- Ineligibility to receive gadofosveset (Gadolinium) 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 clinical contraindications for CRS/HIPEC
- Patients with radiological contra-indications for CRS/HIPEC observed on CT
thorax/abdomen
- Massive mesenteric or small bowel involvement which would lead to short bowel
syndrome if adequately resected
- Extra-peritoneal metastases for which CRS/HIPEC is not justifiable (such as
lung metastases, skeletal metastases, and liver metastases)
- Known additional malignancy, unless treated with curative intent at least
five years ago. In situ cancers, basal cell carcinoma of the skin or squamous
cell carcinoma of the skin that have undergone potentially curative therapy
within the past five years may also be eligible.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Number of preventable unnecessary laparoscopies and explorative laparotomies</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-- Number of additional extra-peritoneal findings<br /><br>- Number of early recurrences (with-in 6 months after R1 resection and HIPEC)<br /><br>- Diagnostic performance of Peritoneal Cancer Index determined by MRI (MRI-PCI)<br /><br>to predict surgical Peritoneal Cancer Index (S-PCI).<br /><br>- Inter-observer agreement between different readers for DW-MRI.<br /><br>- Incremental costs, effects, and incremental cost-effectiveness ratio.<br /><br>- Quality of life between diagnostic arms</p><br>