Pilot Evaluation of the StarGuide Next Generation SPECT/CT System
1 other identifier
interventional
100
1 country
1
Brief Summary
The goal of this pilot study is to evaluate capabilities of the StarGuide NextGen SPECT/CT system to inform future clinical use of this technology.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2025
CompletedFirst Posted
Study publicly available on registry
December 9, 2025
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
February 5, 2026
February 1, 2026
10 months
November 24, 2025
February 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic image quality
Diagnostic image quality of StarGuide NextGen and clinical scans, will be assessed by study radiologists using a Likert scale of 1-5, where 1 = Non-diagnostic; 2 = Poor; 3 = Adequate; 4 = Good; and 5 = Excellent. For future clinical use, acceptable image quality will be considered as having scores of 4 or 5.
1 year
Secondary Outcomes (3)
Count sensitivity
1 year
Lesion contrast
1 year
Signal-to-noise ratio (SNR)
1 year
Study Arms (1)
Nuclear medicine imaging
EXPERIMENTALParticipants presenting to Nuclear Medicine for clinically-indicated administration of radiopharmaceuticals and imaging tests on approved clinical scanners will undergo an additional scan for research purposes on the investigational StarGuide NextGen system.
Interventions
Within 1 hour of the participant receiving a scheduled clinical nuclear medicine procedure, a research scan will be performed with the StarGuide NextGen SPECT/CT system for detection of radiopharmaceutical uptake in the patient body. The total time for the scan will range from 20 - 60 minutes.
Eligibility Criteria
You may qualify if:
- Scheduled for clinical administration of a radiopharmaceutical for a clinical nuclear medicine imaging test or radiopharmaceutical therapy
- Able to provide consent for study participation StarGuide NextGen Evaluation
You may not qualify if:
- Unable to comply with physical requirements for lying supine on the StarGuide NextGen patient bed
- Pregnant. (Note that pregnancy status will be established via clinical standard of care for the clinical nuclear medicine test prior to administration of radiopharmaceutical.)
- Unable to provide consent for study participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- GE Healthcarecollaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Carrie B. Hruska, PhD
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 24, 2025
First Posted
December 9, 2025
Study Start
March 1, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
February 5, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share