Spectral CT Clinical Trial

The objective of this clinical trial was to evaluate the efficacy, ease of operation, stability, and safety of Spectral CT as expected.

Study Overview

• Status: Terminated
• Conditions: Adult ALL
• Intervention / Treatment: Radiation: Spectral CT scanning

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking Union Medical College Hospital
  • Guangzhou, China
    • Nanfang Hospital
  • Xi'an, China
    • The First Hospital of Xian Jiaotong University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Volunteers (ages 18 to 75);
• Negative pregnancy tests for women of childbearing age;
• Agree to participate in the clinical trial and sign the subject informed consent form;
• Enhanced scan requires laboratory evidence of normal renal function.

Exclusion Criteria:

• The body cannot comply with CT examination;
• Pregnant and lactating women;
• Claustrophobia;
• People who are not suitable for enhanced scanning with iodine contrast agent (previous severe heart failure and hyperthyroidism, iodine contrast agent allergy and susceptibility);
• Patients deemed unsuitable for participation in this clinical trial by the investigator.

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;	Radiation: Spectral CT scanning; Volunteer accept spectral CT scanning

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
• Investigators: Study Director: Daming Zhang, Peking Union Medical College Hospital; Principal Investigator: Yikai Xu, Nanfang Hospital of Southern Medical University; Study Director: Ting Liu, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Actual): October 19, 2022
• Study Completion (Actual): February 27, 2023

Study Registration Dates

• First Submitted: March 16, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: CT scanning, image assessment
• Other Study ID Numbers: PD_CT_Hawk_2021_11257

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: No