Role of Magnetic Resonance Enterography for Predicting Peritoneal Cancer Index

Adding Value of Magnetic Resonance Imaging and Magnetic Resonance Enterography for the Pre-operative Assessment of Imaging Peritoneal Cancer Index in Patients With Peritoneal Carcinomatosis

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.

Study Overview

• Status: Recruiting
• Conditions: Peritoneal Carcinomatosis; Cytoreductive Surgery; Hyperthermic Intraperitoneal Chemotherapy
• Intervention / Treatment: Diagnostic test: MRI

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chia-Ni Lin, MA; Phone Number: 2627 +886 5 3621 000; Email: lcn6979@cgmh.org.tw
• Study Contact Backup: Name: Li-Wen Lee, MD, PhD; Phone Number: 2627 +886 5 3621 000; Email: m4572@cgmh.org.tw

Study Locations

• Taiwan
  • Chiayi City, Taiwan, 61363
    • Recruiting
    • Chang Gung Memorial Hospital
    • Contact: Chia-Ni Lin, MA; Phone Number: 2627 +886 5 3621 000; Email: lcn6979@cgmh.org.tw
    • Contact: Li-Wen Lee, MD, PhD; Phone Number: 2627 +886 5 3621 000; Email: m4572@cgmh.org.tw
    • Principal Investigator: Chia-Ni Lin, MA
    • Sub-Investigator: Li-Wen Lee, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Magnetic resonance imaging and enterography following computed tomography; Magnetic resonance imaging and enterography will be performed after computed tomography but before surgery.	Diagnostic test: MRI; Magnetic resonance imaging and enterography before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predicting intraoperative PCI scores for patients with peritoneal carcinomatosis, using MR Enterography and CT	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.	36 months

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Chia-Ni Lin, MA, Chang Gung Memorial Hospital, Chiayi, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): August 31, 2024
• Study Completion (Anticipated): August 31, 2024

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Hyperthermic Intraperitoneal Chemotherapy; Cytoreductive Surgery; Peritoneal Cancer Index; Magnetic Resonance Enterography
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Peritoneal Diseases; Wounds and Injuries; Digestive System Neoplasms; Abdominal Neoplasms; Body Temperature Changes; Heat Stress Disorders; Carcinoma; Peritoneal Neoplasms; Hyperthermia; Fever
• Other Study ID Numbers: 202100965A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No