Colo-rectal CancerNCT07565831
Study on the Prediction of Regional Lymph Node Metastasis in Colorectal Cancer by Spectral CT Combined With MSI
A study testing Investigating the role of spectral CT combined with MSI status in the diagnosis and treatment of colorectal cancer lymph nodes. in people with Colo-rectal Cancer, run by Yunnan Cancer Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- Investigating the role of spectral CT combined with MSI status in the diagnosis and treatment of colorectal cancer lymph nodes.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Colo-rectal Cancer
- Being tested
- Investigating the role of spectral CT combined with MSI status in the diagnosis and treatment of colorectal cancer lymph nodes.
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigating the role of spectral CT combined with MSI status in the diagnosis and treatment of colorectal cancer lymph nodes.Diagnostic test
The CT scan is part of the standard treatment protocol.
| Study group | Role | What they receive |
|---|---|---|
| Study on the prediction of regional lymph node metastasis in colorectal cancer by spectral CT combin | Experimental | 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 Receives: Diagnostic Test: Investigating the role of spectral CT combined with MSI status in the diagnosis and treatment of colorectal cancer lymph nodes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological TNM staging
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start4 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunnan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lianhua Ye, Study director, Ethics Committee of Yunnan Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565831
- Sponsor's protocol ID
- KYLX2025-333
- Status last verified
- Dec 2025
- First submitted
- 27 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Prediction of Regional Lymph Node Metastasis in Colorectal Cancer by Spectral CT Combined With MSI
- ClinicalTrials.gov ID
- NCT07565831
- Acronym / sponsor ID
- KYLX2025-333
- Conditions
- Colo-rectal Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Yunnan Cancer HospitalUniversity, hospital or other
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study on the prediction of regional lymph node metastasis in colorectal cancer by spectral CT combin | Experimental | Diagnostic Test: Investigating the role of spectral CT combined with MSI status in the diagnosis and treatment of colorectal cancer lymph nodes.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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigating the role of spectral CT combined with MSI status in the diagnosis and treatment of colorectal cancer lymph nodes.The CT scan is part of the standard treatment protocol. | Diagnostic test | Study on the prediction of regional lymph node metastasis in colorectal cancer by spectral CT combin |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lianhua Ye study director
Ethics Committee of Yunnan Provincial Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigating the role of spectral CT combined with MSI status in the diagnosis and treatment of colorectal cancer lymph nodes. in people with Colo-rectal Cancer, run by Yunnan Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological TNM staging (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.