Recruiting NCT07661706
Data Collection of New Spectral CT Imaging Method
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Research CT.
- Who it may be relevant to
- Registry conditions: Computed Tomography. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Evaluable Raw Research Scans [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (1)
- Safety Assessment [Time frame: Through study completion, an average of 1 year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- St Luke's University Health Network — Bethlehem
Identifiers
NCT: NCT07661706 · SA-000043