Role of Magnetic Resonance Enterography for Predicting Peritoneal Cancer Index

NCT05063019 | Unknown

• 1 other identifier: 202100965A3
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperthermic Intraperitoneal Chemotherapy; Cytoreductive Surgery; Peritoneal Carcinomatosis

Keywords

Hyperthermic Intraperitoneal Chemotherapy; Cytoreductive Surgery; Peritoneal Cancer Index; Magnetic Resonance Enterography

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Magnetic resonance imaging and enterography following computed tomography

EXPERIMENTAL

Magnetic resonance imaging and enterography will be performed after computed tomography but before surgery.

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

Magnetic resonance imaging and enterography before surgery

Magnetic resonance imaging and enterography following computed tomography

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Chiayi City, 61363, Taiwan

RECRUITING

MeSH Terms

Conditions

Peritoneal Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Study Officials

• Chia-Ni Lin, MA

  Chang Gung Memorial Hospital, Chiayi, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chia-Ni Lin, MA

CONTACT

+886 5 3621 000; lcn6979@cgmh.org.tw

Li-Wen Lee, MD, PhD

CONTACT

+886 5 3621 000; m4572@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 30, 2021
• Study Start: September 1, 2021
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: October 18, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)