SPECT-CT
Conditions
Brief summary
The goal of this study is to collect image data for the StarGuide GX Single Photon Emission Computed Tomography/Computed Tomography (SPECT/CT) System in a clinical setting. The StarGuide GX scan will be compared to the participant's clinically indicated SPECT/CT scanner.
Interventions
DEVICEStarGuide GX SPECT/CT Scan
Participants will undergo two SPECT/CT scans and will be randomized to determine whether imaging with the StarGuide GX scanner or the commercially released reference scanner is performed first. The second scan will begin within one hour of completion of the first scan. No additional tracer will be administered prior to the second imaging session, as both scans will utilize the initially administered dose. Following completion of both scans, participants will be asked to complete a brief questionnaire.
Sponsors
GE Healthcare
Rambam Health Care Campus
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult, who is at least 18 years of age, on day of consent. * Must have a clinically indicated SPECT/CT exam scheduled according to current clinical practice standards; AND * Able and willing to provide informed consent for participation in this study.
Exclusion criteria
* Who, per the site's Standard Operating Procedures (SOPs), has any condition that would prevent the clinically indicated SPECT/CT from proceeding (i.e., pregnancy, breastfeeding, renal impairment, etc.); * Who were previously enrolled in this study; * Who need urgent or emergent care; * Who have any conditions that, in the opinion of the Principal Investigator (PI) or designee, would interfere with the evaluation of the results, or constitute a health hazard for the participant; * Unwilling to have GE Healthcare personnel present during scans; OR * Unable to tolerate the exam.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of StarGuide GX Data Files Collected | Through study completion, an average of 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Number of reference data files | Through study completion, an average of 1 year |
| Number of Participant Questionnaires Collected | Through study completion, an average of 1 year |
Countries
Israel
Contacts
CONTACTErin Terrell, MS
STUDY_DIRECTORBrian Thomsen
GE Healthcare
Outcome results
None listed