Spectral CT Clinical Trial

Adult ALL Clinical Trial

Official title:

Spectral CT Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05361356
• Other study ID #: PD_CT_Hawk_2021_11257
• Status: Terminated
• Phase: N/A
• Start date: March 10, 2022
• Est. completion date: February 27, 2023

Study information

• Verified date: April 2023
• Source: Philips (China) Investment CO., LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: February 27, 2023
• Est. primary completion date: October 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adult ALL

Intervention

Radiation:
• Spectral CT scanning
Volunteer accept spectral CT scanning

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing
China	Nanfang Hospital	Guangzhou
China	The First Hospital of Xian Jiaotong University	Xi'an

Sponsors (1)

Lead Sponsor	Collaborator
Philips (China) Investment CO., LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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