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Not yet recruiting NCT07620444

Spectral Precise Image-Colon Cancer

Observational Colon Cancer Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: This is an observational study.
Who it may be relevant to
Registry conditions: Colon Cancer Patients. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

CT Image Quality Assessment of Colon Cancer Using Spectral Precise Image Deep Learning Reconstruction

Overview

This is a single-center, comparative, observational study. Datasets will be collected from patients with pathologically confirmed colon cancer who undergo abdomen-pelvis enhanced spectral CT scan.

Detailed description

This is a single-center, comparative, observational study. Datasets will be collected from patients with pathologically confirmed colon cancer who undergo abdomen-pelvis enhanced spectral CT scan at investigational center, including retrospective and prospective data. Based on the Dose Right Index (DRI) derived from CT image data, relevant data will be collected at a 1:1 ratio for the conventional radiation dose group (RD group, DRI = 21) and the low radiation dose group (LD group, DRI = 18). A total of 100 cases of datasets is expected to be collected. All CT raw data will be transmitted to Philips after the completion of the de-identification process. For the three-phase data of the LD group (plain scan, arterial phase and venous phase), offline reconstruction will be performed using the Spectral Precise Image algorithm to generate conventional images and VMI-40 keV images. A total of six image sequences will be quantitatively and qualitatively evaluated and compared. For both groups, conventional images and VMI-40 keV images will be reconstructed using iDose4.

Interventions

  • Device This is an observational study
    This is an observational study

Primary outcome measures

  • subjective overall Image quality using 5-point Likert scale(1-5) [Time frame: From the date of image reconstruction completion to the date of image evaluation completion, anticipated 3 Months.]
  • Objective image quality [Time frame: From the date reconstruction completion to the date of image evaluation completion, anticipated 3months.]

Eligibility criteria

Inclusion criteria

  • Patients pathologically confirmed with colon cancer via endoscopic biopsy.
  • Patients who underwent preoperative abdominopelvic enhanced spectral CT.
  • Study participant with age ≥ 18 years old.
  • Study participants that have signed Informed Consent Form (ICF).

Exclusion criteria

  • The clinical data or pathological information is considered incomplete after evaluation by the investigator.
  • The investigator determined that poor image quality (e.g. obvious artifacts, missing critical scan layers) would not satisfy post-processing analysis.
  • Data of patients deemed inappropriate for inclusion after evaluation by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

China · 1 center
  • Sun Yat-sen cancer center — Guangzhou

Identifiers

NCT: NCT07620444 · 301160

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗