NCT07759050

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 chest and abdomen low-dose and routine-dose scans.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

August 11, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

August 3, 2026

Last Update Submit

August 10, 2026

Conditions

Volunteer

Outcome Measures

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.

    From date of image reconstruction until the date of image reading completion, anticipated 1Week.

Secondary Outcomes (1)

  • Image Noise

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

Study Arms (2)

Normal Dose

OTHER
Radiation: CT Radiation Scan

Low Dose

EXPERIMENTAL
Radiation: CT Radiation Scan

Interventions

CT Radiation ScanRADIATION

Use investigated CT do radiation scan

Low DoseNormal Dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

No. 197 Ruijin 2nd road, Huangpu District

Shanghai, Shanghai Municipality, 200020, China

Location

Central Study Contacts

Yan Fu Hua

CONTACT

13661850380Yfh11655@rjh.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2026

First Posted

August 11, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

August 11, 2026

Record last verified: 2026-07

Locations

CN(1)