- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07565831
Study on the Prediction of Regional Lymph Node Metastasis in Colorectal Cancer by Spectral CT Combined With MSI
April 27, 2026 updated by: Yunnan Cancer Hospital
Spectral CT was used to prospectively collect medical images and clinical data related to colorectal cancer, evaluate the effect of image quality in the diagnosis of colorectal cancer, and evaluate the application value in the accurate staging of colorectal cancer, so as to provide a more accurate clinical basis for diagnosis, promote the development of individualized treatment, and ultimately improve the prognosis of patients.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
260
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Yunnan
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Kunming, Yunnan, China, 650000
- Yunnan Cancer Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- (1) Undergo contrast-enhanced Quark energy spectral CT examination of the lower abdomen/pelvis within 1 week before treatment;(2) MSI status confirmed;(3) Age >18 years;(4) Patients with suspected colorectal cancer;(5) Patients who provided informed consent.
Exclusion Criteria:
- (1) Severe cardiac, pulmonary, or renal insufficiency;(2) Allergy to iodine-based contrast agents;(3) Inability to cooperate during the CT examination;(5) Poor image quality from Quark spectral CT scans;(6) Pregnant or lactating women.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study on the prediction of regional lymph node metastasis in colorectal cancer by spectral CT combin
Prospectively collect medical images and clinical data related to colorectal cancer using Philips Quark CT equipment, and evaluate the diagnostic accuracy and clinical application value in the accuratestaging of colorectal cancer.
Patientsdiagnosed with colorectal cancer in Yunnan Provincial Cancer Hospital from August 2025 to December 2026 were consecutively included,and after scanning with Philips Quark CT, the TNM stage of colorectal cancer patients was assessed by two radiologists, and finally statistical analysis was performed
|
The CT scan is part of the standard treatment protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pathological TNM staging
Time Frame: 1 day
|
Pathological examination information: The pathology results using surgery/biopsy data are the gold standard, and the depth of tumor invasion, lymph node metastasis, and distant metastasis are recorded
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Lianhua Ye, Ethics Committee of Yunnan Provincial Cancer Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 4, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
April 27, 2026
First Submitted That Met QC Criteria
April 27, 2026
First Posted (Actual)
May 4, 2026
Study Record Updates
Last Update Posted (Actual)
May 4, 2026
Last Update Submitted That Met QC Criteria
April 27, 2026
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KYLX2025-333
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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