CT ScanningNCT05017233
Spectral CT Clinical Trial Protocol
A study testing Spectral CT in people with CT Scanning, run by Philips (China) Investment CO., LTD at 3 sites in China.
Trial summary
The purpose of this study was to evaluate the expected effectiveness, ease of operation, stability, and safety of Spectral CT Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- CT Scanning
- What is being tested?
- Spectral CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 3 sitesChina
- Study dates
- 4 Jul 2022to 12 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
West China Hospital
Chengdu, Sichuan
Ruijin Hospital
Shanghai
Shanghai Changzheng Hospital
Shanghai
About this study
The purpose of this study was to evaluate the expected effectiveness, ease of operation, stability, and safety of Spectral CT
Read the 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.
- Conditions
- CT Scanning
- Being tested
- Spectral CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectral CTDevice
Using Spectral CT to scan Breast
| Study group | Role | What they receive |
|---|---|---|
| Experimental group, all volunteer will be scanned. | Experimental | All participation accept Spectral CT scanning; No group; Receives: Device: Spectral CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start4 Jul 2022
- Primary completion1 Nov 2022
- Study completion12 Feb 2023
Why it stopped: Investigational product had been released in NMPA, Sponsor decided to terminate the study aligned with investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CT ScanningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips (China) Investment CO., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Changzheng Hospital, Ruijin Hospital, West China Hospital
- Responsible party
- Sponsor
- Investigators
- Shiyuan Liu, Director, Principal investigator, Shanghai Changzheng HospitalFuhua Yan, Director, Principal investigator, Ruijin HospitalBin Song, Director, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017233
- Sponsor's protocol ID
- PD_CT_Hawk_2021_11258
- Status last verified
- May 2024
- First submitted
- 10 Aug 2021
- Last updated
- 17 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectral CT Clinical Trial Protocol
- ClinicalTrials.gov ID
- NCT05017233
- Acronym / sponsor ID
- PD_CT_Hawk_2021_11258
- Conditions
- CT Scanning
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigational product had been released in NMPA, Sponsor decided to terminate the study aligned with investigator
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Philips (China) Investment CO., LTDIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Changzheng Hospital, Ruijin Hospital, West China Hospital
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 12 Feb 2023 (actual)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the expected effectiveness, ease of operation, stability, and safety of 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group, all volunteer will be scanned. | Experimental | Device: Spectral CTAll participation accept Spectral CT scanning; No group; |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spectral CTUsing Spectral CT to scan Breast | Device | Experimental group, all volunteer will be scanned. |
Primary outcome
Excellent and good rate of clinical imaging (score≥3）
Time frame: through study completion, an average of 1 year
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
4 secondary outcomes
Common functions assessment
Time frame: through study completion, an average of 1 year
Convenience evaluation assessment
Time frame: through study completion, an average of 1 year
Machine function and stability assessment
Time frame: through study completion, an average of 1 year
Adverse events and serious adverse events
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: Investigational product had been released in NMPA, Sponsor decided to terminate the study aligned with investigator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiyuan Liu, Director principal investigator
Shanghai Changzheng Hospital
Fuhua Yan, Director principal investigator
Ruijin Hospital
Bin Song, Director principal investigator
West China Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectral CT in people with CT Scanning, run by Philips (China) Investment CO., LTD at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Investigational product had been released in NMPA, Sponsor decided to terminate the study aligned with investigator). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excellent and good rate of clinical imaging (score≥3） (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.