Health TrialsbyHealthPanel

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

ConditionSPECT-CT
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGE Healthcare

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial population

Participants who have a clinically indicated SPECT/CT examination according to current clinical practice standards and according to the data required for the study will be enrolled in this study.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • StarGuide GX SPECT/CT Scan

    Device

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Single Group Study1 intervention

Trial outcomes

Primary outcomes

1

Number of StarGuide GX Data Files Collected

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

Number of reference data files

Time frame
Through study completion, an average of 1 year
2

Number of Participant Questionnaires Collected

Time frame
Through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GE Healthcare

Lead sponsor

Rambam Health Care Campus

Collaborator

Source ClinicalTrials.gov
Apply now