Role of Magnetic Resonance Enterography for Predicting Peritoneal Cancer Index

Not Applicable

Recruiting

• Conditions: Peritoneal Carcinomatosis; Cytoreductive Surgery; Hyperthermic Intraperitoneal Chemotherapy
• Interventions: Diagnostic Test: MRI

• Registration Number: NCT05063019
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

This is a prospective observational study which will recruit 90 participants over a three-year period to investigate whether adding magnetic resonance imaging and enterography to routine computed tomography study can better predict the extend of peritoneal carcinomatosis over computed tomography alone.

Detailed Description

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is a new option for patients with peritoneal carcinomatosis and the effectiveness of HIPEC depends on the extend of disease. Currently, pre-operative imaging peritoneal cancer index (PCI) is used to predict the intraoperative tumor extend and completeness of cytoreduction. However, the investigators' previous study and literature review show that imaging PCI usually underestimated intraoperative PCI, resulting in subsequent Open-Close operation. The investigators hypothesize that magnetic resonance imaging (MRI) is a better predictor of the intra-operative PCI than computed tomography (CT), and MR Enterography can better represent tumor deposits in the small intestine. This study aims to test whether the addition of MRI and MR Enterography to CT study improves the prediction performance of the intraoperative PCI and completeness of optimal cytoreduction over CT alone.

Study Timeline

• Status Verified: 2021-09
• Study Start: 2021-09-01
• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-22
• Study First Posted: 2021-09-30
• Last Update Submitted: 2021-10-08
• Last Update Posted: 2021-10-18
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients with peritoneal carcinomatosis diagnosed by computed tomography
• Schedule for operation at our institute

Exclusion Criteria

• Age < 20 years old
• Renal function impairment or acute renal failure
• Contraindications for magnetic resonance imaging
• Primary tumor not origins from colorectal cancer, gastric cancer or ovarian cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Magnetic resonance imaging and enterography following computed tomography	MRI	Magnetic resonance imaging and enterography will be performed after computed tomography but before surgery.

Primary Outcome Measures

Name	Time	Method
Predicting intraoperative PCI scores for patients with peritoneal carcinomatosis, using MR Enterography and CT	36 months	The Sugarbaker's Peritoneal Cancer Index scores according to the MR enterography and CT images will be calculated pre-operatively and will be compared to the standard PCI scores obtained during operation. Basically, the scoring system divides the abdominopelvic cavity into 13 separate regions, and each region is scored 0-3 points as follows: 0 point, the absence of tumor; 1 point, tumors \< 0.5 cm in diameter; 2 points, tumors 0.5-5 cm in diameter; 3 points, tumors \> 5 cm in diameter.

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Chiayi City, Taiwan