Role of Magnetic Resonance Enterography for Predicting Peritoneal Cancer Index
Primary Purpose
Hyperthermic Intraperitoneal Chemotherapy, Cytoreductive Surgery, Peritoneal Carcinomatosis
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Hyperthermic Intraperitoneal Chemotherapy focused on measuring Hyperthermic Intraperitoneal Chemotherapy, Cytoreductive Surgery, Peritoneal Cancer Index, Magnetic Resonance Enterography
Eligibility Criteria
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
Sites / Locations
- Chang Gung Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Magnetic resonance imaging and enterography following computed tomography
Arm Description
Magnetic resonance imaging and enterography will be performed after computed tomography but before surgery.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05063019
First Posted
September 13, 2021
Last Updated
October 8, 2021
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05063019
Brief Title
Role of Magnetic Resonance Enterography for Predicting Peritoneal Cancer Index
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperthermic Intraperitoneal Chemotherapy, Cytoreductive Surgery, Peritoneal Carcinomatosis
Keywords
Hyperthermic Intraperitoneal Chemotherapy, Cytoreductive Surgery, Peritoneal Cancer Index, Magnetic Resonance Enterography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Magnetic resonance imaging and enterography following computed tomography
Arm Type
Experimental
Arm Description
Magnetic resonance imaging and enterography will be performed after computed tomography but before surgery.
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI
Intervention Description
Magnetic resonance imaging and enterography before surgery
Primary Outcome Measure Information:
Title
Predicting intraoperative PCI scores for patients with peritoneal carcinomatosis, using MR Enterography and CT
Description
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.
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chia-Ni Lin, MA
Phone
+886 5 3621 000
Ext
2627
Email
lcn6979@cgmh.org.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Li-Wen Lee, MD, PhD
Phone
+886 5 3621 000
Ext
2627
Email
m4572@cgmh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Ni Lin, MA
Organizational Affiliation
Chang Gung Memorial Hospital, Chiayi, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Chiayi City
ZIP/Postal Code
61363
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chia-Ni Lin, MA
Phone
+886 5 3621 000
Ext
2627
Email
lcn6979@cgmh.org.tw
First Name & Middle Initial & Last Name & Degree
Li-Wen Lee, MD, PhD
Phone
+886 5 3621 000
Ext
2627
Email
m4572@cgmh.org.tw
First Name & Middle Initial & Last Name & Degree
Chia-Ni Lin, MA
First Name & Middle Initial & Last Name & Degree
Li-Wen Lee, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be available to other researchers.
Learn more about this trial
Role of Magnetic Resonance Enterography for Predicting Peritoneal Cancer Index
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