Role of Magnetic Resonance Enterography for Predicting Peritoneal Cancer Index

Peritoneal Carcinomatosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05063019
• Other study ID #: 202100965A3
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: September 2021
• Source: Chang Gung Memorial Hospital
• Contact: Chia-Ni Lin, MA
• Phone: +886 5 3621 000
• Email: lcn6979[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Cytoreductive Surgery
• Fever
• Hyperthermia
• Hyperthermic Intraperitoneal Chemotherapy
• Peritoneal Carcinomatosis
• Peritoneal Neoplasms

Intervention

Diagnostic Test:
• MRI
Magnetic resonance imaging and enterography before surgery

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Chiayi City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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