Data Collection of New Spectral CT Imaging Method

NCT07661706 | Recruiting FDA Device

• 1 other identifier: SA-000043
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Computed Tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety Assessment

  Through study completion, an average of 1 year

Study Arms (1)

Research CT

Device: Research CT

Interventions

Research CT DEVICE

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.

Research CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

St Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

RECRUITING

Study Officials

• Brian Thomsen

  GE Healthcare

  STUDY DIRECTOR

Central Study Contacts

Melissa Challman, MPH, CCRP

CONTACT

18582213007; melissa.challman@gehealthcare.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: June 22, 2026
• Study Start: December 19, 2025
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)