SPECT/CT Prospective Double-Scanning Study

NCT07725237 | Not Yet Recruiting FDA Device

• 1 other identifier: SA-000219
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SPECT-CT

Outcome Measures

Primary Outcomes (1)

• Number of StarGuide GX Data Files Collected

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• 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

Study Arms (1)

Single Group Study

Adult patients scheduled to undergo a clinically indicated SPECT/CT

Device: StarGuide GX SPECT/CT Scan

Interventions

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.

Single Group Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead
• Rambam Health Care Campus: collaborator

Study Sites (1)

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Study Officials

• Brian Thomsen

  GE Healthcare

  STUDY DIRECTOR

Central Study Contacts

Erin Terrell, MS

CONTACT

1 262 449 3363; erin.terrell@gehealthcare.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 24, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)