Study Stopped
Investigational product had been released in NMPA, Sponsor decided to terminate the study aligned with investigator
Spectral CT Clinical Trial Protocol
1 other identifier
interventional
51
1 country
3
Brief Summary
The purpose of this study was to evaluate the expected effectiveness, ease of operation, stability, and safety of Spectral CT
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2022
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2021
CompletedFirst Posted
Study publicly available on registry
August 23, 2021
CompletedStudy Start
First participant enrolled
July 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2023
CompletedMay 17, 2024
May 1, 2024
4 months
August 10, 2021
May 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Common functions assessment
through study completion, an average of 1 year
Convenience evaluation assessment
through study completion, an average of 1 year
Machine function and stability assessment
through study completion, an average of 1 year
Adverse events and serious adverse events
through study completion, an average of 1 year
Study Arms (1)
Experimental group, all volunteer will be scanned.
EXPERIMENTALAll participation accept Spectral CT scanning; No group;
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Philips (China) Investment CO., LTDlead
- Shanghai Changzheng Hospitalcollaborator
- Ruijin Hospitalcollaborator
- West China Hospitalcollaborator
Study Sites (3)
West China Hospital
Chengdu, Sichuan, China
Ruijin Hospital
Shanghai, China
Shanghai Changzheng Hospital
Shanghai, China
Study Officials
- PRINCIPAL INVESTIGATOR
Shiyuan Liu, Director
Shanghai Changzheng Hospital
- PRINCIPAL INVESTIGATOR
Fuhua Yan, Director
Ruijin Hospital
- PRINCIPAL INVESTIGATOR
Bin Song, Director
West China Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2021
First Posted
August 23, 2021
Study Start
July 4, 2022
Primary Completion
November 1, 2022
Study Completion
February 12, 2023
Last Updated
May 17, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share