NCT07272161

Pilot Evaluation of the StarGuide Next Generation SPECT/CT System

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nuclear Medicine

Interventions

Type	Name	Description
DEVICE	StarGuide 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.

Timeline

• Start date: 2026-03-25
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-12-09
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study