Data Collection of New Spectral CT Imaging Method | NCT07661706

Studies
Data Collection of New Spectral CT Imaging Method

NCT07661706

Sponsor

GE Healthcare

Status

Recruiting

Last Update Posted

Jun 22, 2026Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Computed Tomography

Interventions

Research CT

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 19, 2025Actual

Primary Completion Date

Aug 2026Estimated

Completion Date

Aug 2026Estimated

First Submitted Date

Apr 24, 2026

First Submission Date that Met QC Criteria

Jun 16, 2026

First Posted Date

Jun 22, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2026

Last Update Posted Date

Jun 22, 2026Actual

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Research CT			Device: Research CT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Melissa Challman, MPH, CCRP	Contact	18582213007		melissa.challman@gehealthcare.com

Overall Officials

Name	Affiliation	Role
Brian Thomsen	GE Healthcare	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Luke's University Health Network	Recruiting	Bethlehem	Pennsylvania	18015	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided