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Enrolling by Invitation

NCT Number: NCT07272161

Pilot Evaluation of the StarGuide Next Generation SPECT/CT System

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.

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Key information

Conditions

Nuclear Medicine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

StarGuide NextGen SPECT/CT system

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Count sensitivity

    Time frame: 1 year

  2. Lesion contrast

    Time frame: 1 year

  3. Signal-to-noise ratio (SNR)

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • GE Healthcare

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 9, 2025
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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