Data Collection of New Spectral CT Imaging Method

The purpose of the study is to collect data to evaluate utility of a next generation spectral CT system in a clinical setting.

Study Overview

• Status: Recruiting
• Conditions: Computed Tomography
• Intervention / Treatment: Device: Research CT

Detailed Description

Data collected in this study includes an assessment of image quality parameters to evaluate the product. This data and analysis will help support regulatory submissions.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Melissa Challman, MPH, CCRP; Phone Number: 18582213007; Email: melissa.challman@gehealthcare.com

Study Locations

• United States
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • Recruiting
      • St Luke's University Health Network
      • Contact: Monica Hosler; Phone Number: 484-658-4567; Email: monica.hosler@sluhn.org
      • Principal Investigator: Pallav N Shah, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The subject population will consist of adults that are 18-years of age or older who in the past 90 days or will in the future 30 days of the investigational scan undergo a clinically indicated CT exam within the St. Luke's University Hospital Network of the neck, chest, abdomen, pelvis, or extremities.

Description

Inclusion Criteria:

• Who are ≥18 years of age;
• Able to sign and date the informed consent form; AND,
• Who have in the past 90 days or will in the future 30 days of the investigational scan undergo a clinically indicated CT exam within the St. Luke's University Hospital Network of the neck, chest, abdomen, pelvis, or extremities.

Exclusion Criteria:

• Who are pregnant or lactating;
• Who were previously enrolled in this study;
• For planned contrast-enhanced investigational CT exams, anyone with known or suspected allergy to iodinated contrast agents;
• For planned contrast-enhanced investigational CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel;
• Who need urgent or emergent care;
• Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject; OR,
• Who are unwilling to have GEHC personnel present for the CT exam.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Research CT	Device: Research CT; Participants will undergo a research CT on an investigational Spectral CT Imaging scanner which will be matched to their prior or scheduled SOC CT. Scans will be matched on anatomy, radiation dose, and contrast administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluable Raw Research Scans	Number of participants who research scan is deemed evaluable (i.e., no issues with participant motion or contrast administration/timing)	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Assessment	Number of Adverse Events and/or Serious Adverse Events reported.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Study Director: Brian Thomsen, GE Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SA-000043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes