Pilot Evaluation of the StarGuide Next Generation SPECT/CT System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: StarGuide NextGen SPECT/CT system.
- Who it may be relevant to
- Registry conditions: Nuclear Medicine. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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.
Primary outcome measures
- Diagnostic image quality [Time frame: 1 year]
Secondary outcome measures (3)
- Count sensitivity [Time frame: 1 year]
- Lesion contrast [Time frame: 1 year]
- Signal-to-noise ratio (SNR) [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Identifiers
NCT: NCT07272161 · 25-010203