SPECT-CTNCT07725237
Single Photon Emission Computed Tomography/Computed Tomography (SPECT/CT) Prospective Double-Scanning Study
An observational study of SPECT-CT, run by GE Healthcare at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SPECT-CT
- What is being tested?
- StarGuide GX SPECT/CT Scan
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Jul 2026to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Rambam Health Care Campus
Haifa, 3109601
Chen TIKOTZKI, 972 054-4833981, C_TIKOTZKI@rambam.health.gov.il
Zohar Keidar, MD
About this study
Official title: Demonstration of the StarGuide GX SPECT/CT System
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.
- Conditions
- SPECT-CT
- Being tested
- StarGuide GX SPECT/CT Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Group Study | Adult patients scheduled to undergo a clinically indicated SPECT/CT Receives: Device: StarGuide GX SPECT/CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of StarGuide GX Data Files Collected
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Number of reference data files
Measured: Through study completion, an average of 1 year
Number of Participant Questionnaires Collected
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start20 Jul 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SPECT-CTStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rambam Health Care Campus
- Responsible party
- Sponsor
- Investigators
- Brian Thomsen, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725237
- Sponsor's protocol ID
- SA-000219
- Status last verified
- Aug 2026
- First submitted
- 21 Jul 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration of the StarGuide GX SPECT/CT System
- ClinicalTrials.gov ID
- NCT07725237
- Acronym / sponsor ID
- SA-000219
- Conditions
- SPECT-CT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Rambam Health Care Campus
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Study | – | Device: StarGuide GX SPECT/CT ScanAdult patients scheduled to undergo a clinically indicated SPECT/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StarGuide GX SPECT/CT ScanParticipants 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. | Device | Single Group Study |
Primary outcome
Number of StarGuide GX Data Files Collected
Time frame: Through study completion, an average of 1 year
2 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian Thomsen study director
GE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SPECT-CT, run by GE Healthcare at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Terrell, MS (1 262 449 3363, erin.terrell@gehealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of StarGuide GX Data Files Collected (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.