Spectral Precise Image-Colon Cancer

N/ANot Yet RecruitingNCT07620444

Philips Clinical & Medical Affairs Global100 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Colon Cancer Patients

Interventions

This is an observational studyDEVICE

This is an observational study

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients pathologically confirmed with colon cancer via endoscopic biopsy. 2. Patients who underwent preoperative abdominopelvic enhanced spectral CT. 3. Study participant with age ≥ 18 years old. 4. Study participants that have signed Informed Consent Form (ICF). Exclusion Criteria: 1. The clinical data or pathological information is considered incomplete after evaluation by the investigator. 2. The investigator determined that poor image quality (e.g. obvious artifacts, missing critical scan layers) would not satisfy post-processing analysis. 3. Data of patients deemed inappropriate for inclusion after evaluation by the investigator.

Locations (1)

Sun Yat-sen cancer center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

subjective overall Image quality using 5-point Likert scale(1-5)

Radiologist will evaluate the overall image quality using 5 Likert scale ranging from 1(poor) to 5 (Excellent)

Time frame: From the date of image reconstruction completion to the date of image evaluation completion, anticipated 3 Months.

Objective image quality

The objective image quality is evaluated by measuring the CT value shown in the image.

Time frame: From the date reconstruction completion to the date of image evaluation completion, anticipated 3months.

Central Contacts

Miao Chuan Xie

CONTACT

+8618903050011 xiechm@sysucc.org.cn

Data from ClinicalTrials.gov

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