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The Value of MRI in Assessing the Status of Retroperitoneal Resection Margin in Colon Cancer

Primary Purpose

Colon Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Beyond complete mesocolic excision surgery
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colon Cancer focused on measuring Colon cancer, MRI, Resection margin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: primary colon adenocarcinoma confirmed by biopsy preoperative CT suspecting retroperitoneal resection margin (RPRM) positive received colon MRI scan underwent beyond complete mesocolic excision surgery sufficient clinical and pathological results Exclusion Criteria: combined with other malignant tumors simultaneous distant metastasis definite invaded other organs or structures (T4b tumors)

Sites / Locations

  • Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Suspected positive RPRM on MRI

Arm Description

Outcomes

Primary Outcome Measures

Coincidence rate with pathological result
Coincidence rate between MRI diagnosed retroperitoneal resection margin and pathologically confirmed positive

Secondary Outcome Measures

Full Information

First Posted
May 5, 2023
Last Updated
May 5, 2023
Sponsor
Peking University Cancer Hospital & Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05859581
Brief Title
The Value of MRI in Assessing the Status of Retroperitoneal Resection Margin in Colon Cancer
Official Title
To Explore the Value of Colon MRI in Assessing the Status of Retroperitoneal Resection Margin Following Beyond Complete Mesocolic Excision Surgery for Advanced Colon Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2, 2023 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Cancer Hospital & Institute

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
The goal of this clinical trial is to explore the value of colon MRI in assessing the status of retroperitoneal resection margin (RPRM) for advanced colon cancer. The main questions it aims to answer are: Concordance between MRI suspected RPRM positive and pathologically confirmed positive. Can RPRM-positive patients undergo beyond complete mesocolic excision (CME) surgery in order to achieve R0 resection? Participants will undergo colon MRI examination and once MRI suspects RPRM positive, they will receive beyond CME surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
Colon cancer, MRI, Resection margin

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Suspected positive RPRM on MRI
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Beyond complete mesocolic excision surgery
Intervention Description
If the participants were diagnosed with positive retroperitoneal resection margin (RPRM), they underwent beyond complete mesocolic excision surgery to ensure the R0 resection.
Primary Outcome Measure Information:
Title
Coincidence rate with pathological result
Description
Coincidence rate between MRI diagnosed retroperitoneal resection margin and pathologically confirmed positive
Time Frame
within 2 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary colon adenocarcinoma confirmed by biopsy preoperative CT suspecting retroperitoneal resection margin (RPRM) positive received colon MRI scan underwent beyond complete mesocolic excision surgery sufficient clinical and pathological results Exclusion Criteria: combined with other malignant tumors simultaneous distant metastasis definite invaded other organs or structures (T4b tumors)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen Guan, MD
Phone
861088196825
Email
18801231091@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying-Shi Sun, MD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen Guan, MD
Phone
861088196825
Email
18801231091@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Value of MRI in Assessing the Status of Retroperitoneal Resection Margin in Colon Cancer

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