Single Photon Emission Computed Tomography/Computed Tomography (SPECT/CT) Prospective Double-Scanning Study

GE Healthcare30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

SPECT-CT

Interventions

StarGuide GX SPECT/CT ScanDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Rambam Health Care Campus

Haifa, Israel

RECRUITING

Outcomes

Primary Outcomes

Number of StarGuide GX Data Files Collected

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

Secondary Outcomes

Number of reference data files

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

Number of Participant Questionnaires Collected

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

Central Contacts

Erin Terrell, MS

CONTACT

1 262 449 3363 erin.terrell@gehealthcare.com

Data from ClinicalTrials.gov

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