Clinical Study of Spectral CT Verida

ConditionVolunteers
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPhilips Clinical & Medical Affairs Global

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • CT Radiation Scan

    Radiation

    Use investigated CT do radiation scan

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Normal DoseOther 1 intervention
Group B: Low doseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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.

Time frame
From Image reconstruction to image noise recording finished,estimate 1Week.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Philips Clinical & Medical Affairs Global

Lead sponsor

Qilu Hospital of Shandong University

Collaborator

This trial is not recruiting at the moment. You can still explore other options: