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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52404

Enrollment

192

Registered

2019-09-13

Start date

2019-11-13

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastasis colorectal cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Number of preventable unnecessary laparoscopies and explorative laparotomies	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results