Data Collection of New Spectral CT Imaging Method
ConditionComputed Tomography
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGE Healthcare
About this trial
The purpose of the study is to collect data to evaluate utility of a next generation spectral CT system in a clinical setting.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial 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.
Trial design
Design model
Case-only
Time perspective
Other
Treatments tested in this trial
Research CT
DeviceParticipants 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Research CT1 intervention
Trial outcomes
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)
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
Safety Assessment
Number of Adverse Events and/or Serious Adverse Events reported.
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov