Pilot Evaluation of the StarGuide Next Generation SPECT/CT System

Mayo Clinic

Status: Begins enrollment this month

Conditions: Nuclear Medicine

Treatments: Device: StarGuide NextGen SPECT/CT system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07272161

25-010203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Nuclear medicine imaging

Experimental group

Description:

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.

Treatment:

Device: StarGuide NextGen SPECT/CT system