MedDataX Logo

Role of Magnetic Resonance Enterography for Predicting Peritoneal Cancer Index

NCT ID: NCT05063019

Last Updated: 2021-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2024-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperthermic Intraperitoneal Chemotherapy Cytoreductive Surgery Peritoneal Carcinomatosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Magnetic resonance imaging and enterography following computed tomography

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

Group Type EXPERIMENTAL

MRI

Intervention Type DIAGNOSTIC_TEST

Magnetic resonance imaging and enterography before surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MRI

Magnetic resonance imaging and enterography before surgery

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chia-Ni Lin, MA

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital, Chiayi, Taiwan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chang Gung Memorial Hospital

Chiayi City, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Chia-Ni Lin, MA

Role: CONTACT

[email protected]
+886 5 3621 000 ext. 2627

Li-Wen Lee, MD, PhD

Role: CONTACT

[email protected]
+886 5 3621 000 ext. 2627

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Chia-Ni Lin, MA

Role: primary

[email protected]
+886 5 3621 000 ext. 2627

Li-Wen Lee, MD, PhD

Role: backup

[email protected]
+886 5 3621 000 ext. 2627

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

202100965A3

Identifier Type: -

Identifier Source: org_study_id