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Pilot Evaluation of the StarGuide Next Generation SPECT/CT System

Pilot Evaluation of the StarGuide Next Generation SPECT/CT System

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07272161
Enrollment
100
Registered
2025-12-09
Start date
2026-03-25
Completion date
2027-01-01
Last updated
2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nuclear Medicine

Keywords

SPECT/CT

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.

Detailed description

The StarGuide NextGen system is expected to offer superior image quality and faster scanning times relative to our standard clinical SPECT systems. However, the optimal scanning parameters for StarGuide NextGen are yet undetermined. This research study is necessary to assess the feasibility of patient scanning on this system and to refine the parameters in preparation for future clinical use. The study is also important to inform whether and to what degree the StarGuide NextGen can improve image quality over standard dual-head SPECT/CT scanners for a variety of common nuclear medicine exams.

Interventions

DEVICEStarGuide NextGen SPECT/CT system

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.

Sponsors

Mayo Clinic
Lead SponsorOTHER
GE Healthcare
CollaboratorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic image quality1 yearDiagnostic 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.

Secondary

MeasureTime frame
Count sensitivity1 year
Lesion contrast1 year
Signal-to-noise ratio (SNR)1 year

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORCarrie B. Hruska, PhD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026