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Clinical Study of Spectral CT Verida

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07759011
Enrollment
80
Registered
2026-08-11
Start date
2026-07-30
Completion date
2027-06-30
Last updated
2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Volunteers

Brief 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 scans.

Interventions

Use investigated CT do radiation scan

Sponsors

Philips Clinical & Medical Affairs Global
Lead SponsorINDUSTRY
Qilu Hospital of Shandong University
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
The rate of good-excellent scores ≥3From 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.

Secondary

MeasureTime frameDescription
Objective outcome:Image NoiseFrom Image reconstruction to image noise recording finished,estimate 1Week.Will use FAS,PSS,SS do the image noise (parameters record)datasets analysis.

Countries

China

Contacts

CONTACTYu De Xin
ydx0330@sina.com+8618560081629

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026