Role of Magnetic Resonance Enterography for Predicting Peritoneal Cancer Index

NCT05063019 — Not applicable, Unknown, 90 participants, Chang Gung Memorial Hospital

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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

Registry	NCT05063019
Status	Unknown
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	90 (Estimated)
Sponsor	Chang Gung Memorial Hospital (Other)
Conditions	Hyperthermic Intraperitoneal Chemotherapy, Cytoreductive Surgery, Peritoneal Carcinomatosis
Interventions	MRI (Diagnostic test)
Dates	start 2021-09-01, primary completion 2024-08-31 (estimated), completion 2024-08-31 (estimated), first posted 2021-09-30, last updated 2021-10-18
Locations	1 site in Taiwan

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Magnetic resonance imaging and enterography following computed tomography	Experimental	Diagnostic Test: MRI	Magnetic resonance imaging and enterography will be performed after computed tomography but before surgery.

MRI (Diagnostic test): Magnetic resonance imaging and enterography before surgery

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: 20 Years to 80 Years

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

+Locations (1)

Facility	City	Country	Status
Chang Gung Memorial Hospital	Chiayi City	Taiwan	Recruiting

+Investigators

Chia-Ni Lin, MA, Principal investigator, Chang Gung Memorial Hospital, Chiayi, Taiwan

My Notes

Public

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