Pilot Evaluation of the StarGuide Next Generation SPECT/CT System

March 31, 2026 updated by: Carrie Hruska, Mayo Clinic
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nuclear medicine imaging
Participants 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic image quality
Time Frame: 1 year
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 Outcome Measures

Outcome Measure
Time Frame
Count sensitivity
Time Frame: 1 year
1 year
Lesion contrast
Time Frame: 1 year
1 year
Signal-to-noise ratio (SNR)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

GE Healthcare

Investigators

  • Principal Investigator: Carrie B. Hruska, PhD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 24, 2025

First Submitted That Met QC Criteria

December 7, 2025

First Posted (Actual)

December 9, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 25-010203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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