Spectral CT Clinical Trial Protocol

The purpose of this study was to evaluate the expected effectiveness, ease of operation, stability, and safety of Spectral CT

Study Overview

• Status: Terminated
• Conditions: CT Scanning
• Intervention / Treatment: Device: Spectral CT

Detailed Description

Under the premise of protecting subjects and ensuring the scientific nature of this study, Spectral CT was evaluated for its effectiveness, convenience, stability and safety under normal conditions by collecting clinical cases.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Changzheng Hospital
  • Shanghai, China
    • Ruijin Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Study Population

volunteers (ages 18 to 75)

Description

Inclusion Criteria:

• Recruit volunteers (ages 18 to 75);
• Negative pregnancy tests in women of childbearing age;
• Participants who agree to participate in this clinical trial and sign the informed consent;
• Enhanced scans require laboratory tests to confirm normal renal function.

Exclusion Criteria:

• Persons who do not have full capacity for civil conduct;
• Lactating women;
• People who are not suitable for enhanced scanning with iodine contrast agent;
• Patients whom the investigator considers inappropriate to participate in this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group, all volunteer will be scanned.; All participation accept Spectral CT scanning; No group;	Device: Spectral CT; Using Spectral CT to scan Breast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Excellent and good rate of clinical imaging (score≥3）	Rated items 5 points Excellent image quality for diagnostic purposes, very satisfactory 4 points good image quality, can be used for diagnosis, satisfactory 3 points Image quality defects, do not affect the diagnosis, general 2. Unsatisfactory image quality, affecting diagnosis Poor image quality, undiagnosable, unsatisfactory	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Common functions assessment	Common function evaluation items inclduing:The exposure function; Bed body moving; Microphone intercom function; Image post-processing function; Data storage management. With Satisfied, normal, Not Satisfied	through study completion, an average of 1 year
Convenience evaluation assessment	Convenience function evaluation items inclduing:Laser positioning lamp Breathing navigation Control buttons The clinical interface friendliness of postprocessing software The post-processing software is convenient for clinical use and operation. With Satisfied, normal, Not Satisfied	through study completion, an average of 1 year
Machine function and stability assessment	Machine function and stability evaluation items inclduing:workflow Image display and transmission Failed to start system Unexpected system shutdown Abnormal termination during the scan Unable to expose during scan. With Satisfied, normal, Not Satisfied	through study completion, an average of 1 year
Adverse events and serious adverse events	Adverse events and serious adverse events during the test were collected to evaluate the safety of the product.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Philips (China) Investment CO., LTD
• Collaborators: West China Hospital; Ruijin Hospital; Shanghai Changzheng Hospital
• Investigators: Principal Investigator: Shiyuan Liu, Director, Shanghai Changzheng Hospital; Principal Investigator: Fuhua Yan, Director, Ruijin Hospital; Principal Investigator: Bin Song, Director, West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2022
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): February 12, 2023

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 23, 2021

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PD_CT_Hawk_2021_11258

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes