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NCT Number: NCT07725237

SPECT/CT Prospective Double-Scanning Study

The goal of this study is to collect image data for StarGuide GX SPECT/CT System in a clinical setting. The StarGuide GX scan will be compared to the participant's clinically indicated SPECT/CT scanner. Participants will be adult patients scheduled to undergo a clinically indicated SPECT/CT.

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Key information

Conditions

SPECT-CT

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult, who is at least 18 years of age, on day of consent.
  • Must have a clinical 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 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 PI or designee, would interfere with the evaluation of the results, constitute a health hazard for the participant;
  • Unwilling to have GEHC personnel present during scans; OR
  • Unable to tolerate the exam.

Treatment and study plan

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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Terrell, MS

CONTACT

[email protected]

1 262 449 3363

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Collaborators

  • Rambam Health Care Campus

Registry information

Official study title

Demonstration of the StarGuide GX SPECT/CT System

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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