VolunteersNCT07759011
Clinical Study of Spectral CT Verida
A study testing CT Radiation Scan in people with Volunteers, run by Philips Clinical & Medical Affairs Global at 1 site in China.
Trial summary
This study will prospective enroll 80 subjects to evaluate the comparison of image quality, proportion of high-quality images, and image noise between the Spectral Precise Image (SPI) intelligent denoising for low-dose scans on the Spectral CT Verida system and iDose4 reconstructions after low-dose and routine-dose… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Volunteers
- What is being tested?
- CT Radiation Scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 18 ≤ age ≤ 75 years.
- 18 kg/m² ≤ BMI ≤ 28 kg/m².
- Conscious, able to cooperate, and competent to perform study procedures. Voluntarily agrees to participate in this clinical study and has signed the informed consent form.
- Women of childbearing potential must have a negative pregnancy test and have no plans to become pregnant during the next 6 months.
Who cannot join
- Persons without full civil capacity.
- Pregnant or breastfeeding women.
- Any other conditions that, in the investigator's judgment, make the subject unsuitable for participation in this clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
No. 107 Wenhua West Road, Lixia District
Jinan, Shandong, 250011
Zhao Shi Liang, 0531-82166666, qlyygcp_mms@qiluhospital.com
About this study
Official title: Prospective, Single-Center Evaluation of Image Quality for Low-Dose Scans With Spectral Precise Image (SPI) Intelligent Denoising Versus iDose4 Reconstructions for Low- and Standard-Dose Scans - Clinical Study Protocol
This study will prospective enroll 80 subjects to evaluate the comparison of image quality, proportion of high-quality images, and image noise between the Spectral Precise Image (SPI) intelligent denoising for low-dose scans on the Spectral CT Verida system and iDose4 reconstructions after low-dose and routine-dose scans.
- Conditions
- Volunteers
- Being tested
- CT Radiation Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT Radiation ScanRadiation
Use investigated CT do radiation scan
| Study group | Role | What they receive |
|---|---|---|
| Normal Dose | Other | Not described Receives: Radiation: CT Radiation Scan |
| Low dose | Experimental | Not described Receives: Radiation: CT Radiation Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of good-excellent scores ≥3
Image quality will be assessed by 2 radiologists using Likert-scale on a range from 1(poor) to 5(Excellent),and calculate the rate of ≥3 with FAS,PSS SS as the datasets analysis.
Measured: From date of image reconstruction until the date of image reading completion, anticipated 1Week.
Secondary outcomes (1)
Objective outcome:Image Noise
Will use FAS,PSS,SS do the image noise (parameters record)datasets analysis.
Measured: From Image reconstruction to image noise recording finished，estimate 1Week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start30 Jul 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VolunteersStudies of the same condition, open and under way.
- More trials run by Philips Clinical & Medical Affairs GlobalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Qilu Hospital of Shandong University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759011
- Sponsor's protocol ID
- SEF-2025-301637
- Status last verified
- Jun 2026
- First submitted
- 3 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sponsor and site need further discuss.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-Center Evaluation of Image Quality for Low-Dose Scans With Spectral Precise Image (SPI) Intelligent Denoising Versus iDose4 Reconstructions for Low- and Standard-Dose Scans - Clinical Study Protocol
- ClinicalTrials.gov ID
- NCT07759011
- Acronym / sponsor ID
- SEF-2025-301637
- Conditions
- Volunteers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Collaborators
- Qilu Hospital of Shandong University
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 11 Aug 2026 (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.
This study will prospective enroll 80 subjects to evaluate the comparison of image quality, proportion of high-quality images, and image noise between the Spectral Precise Image (SPI) intelligent denoising for low-dose scans on the Spectral CT Verida system and iDose4 reconstructions after low-dose and routine-dose scans.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Dose | Other | Radiation: CT Radiation Scan |
| Low dose | Experimental | Radiation: CT Radiation Scan |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 ≤ age ≤ 75 years.
- 18 kg/m² ≤ BMI ≤ 28 kg/m².
- Conscious, able to cooperate, and competent to perform study procedures. Voluntarily agrees to participate in this clinical study and has signed the informed consent form.
- Women of childbearing potential must have a negative pregnancy test and have no plans to become pregnant during the next 6 months.
Key exclusion criteria (3 listed)
- Persons without full civil capacity.
- Pregnant or breastfeeding women.
- Any other conditions that, in the investigator's judgment, make the subject unsuitable for participation in this clinical study.
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 |
|---|---|---|
| CT Radiation ScanUse investigated CT do radiation scan | Radiation | Low dose, Normal Dose |
Primary outcome
The rate of good-excellent scores ≥3
Time frame: From date of image reconstruction until the date of image reading completion, anticipated 1Week.
Image quality will be assessed by 2 radiologists using Likert-scale on a range from 1(poor) to 5(Excellent),and calculate the rate of ≥3 with FAS,PSS SS as the datasets analysis.
1 secondary outcome
Objective outcome:Image Noise
Time frame: From Image reconstruction to image noise recording finished，estimate 1Week.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Undecided. Sponsor and site need further discuss.
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Screening Protocol
Pain
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT Radiation Scan in people with Volunteers, run by Philips Clinical & Medical Affairs Global at 1 site 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 3 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: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu De Xin (+8618560081629, ydx0330@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of good-excellent scores ≥3 (time frame: From date of image reconstruction until the date of image reading completion, anticipated 1Week.). 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 11 Aug 2026.