Data Collection of New Spectral CT Imaging Method

GE Healthcare50 enrolled

Overview

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

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

Conditions

Computed Tomography

Interventions

Research CTDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

St Luke's University Health Network

Bethlehem, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

Evaluable Raw Research Scans

Number of participants who research scan is deemed evaluable (i.e., no issues with participant motion or contrast administration/timing)

Time frame: Through study completion, an average of 1 year

Secondary Outcomes

Safety Assessment

Number of Adverse Events and/or Serious Adverse Events reported.

Time frame: Through study completion, an average of 1 year

Central Contacts

Melissa Challman, MPH, CCRP

CONTACT

18582213007 melissa.challman@gehealthcare.com

Data from ClinicalTrials.gov

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