StarGuide NextGen SPECT/CT for Radiology

Overseen By Brevin Ndovu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Inability to lie supine, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of the StarGuide NextGen SPECT/CT system for future medical imaging use. It involves individuals already scheduled to receive a radiopharmaceutical, a special medicine used in imaging tests, as part of their regular care. Participants must be able to lie flat during the scan and provide consent to join. The study aims to determine if this new system could enhance future imaging options. As an unphased trial, it offers a unique opportunity to contribute to advancements in medical imaging technology.

What prior data suggests that the StarGuide NextGen SPECT/CT system is safe for use in radiology?

Research has shown that the StarGuide NextGen SPECT/CT system is designed for nuclear medicine imaging. This system uses advanced technology to capture clear images of the body. Generally, systems like this are easy for patients to manage.

The StarGuide system enables doctors to observe how diseases affect the body. It does not involve direct treatment, so serious side effects are uncommon. It is similar to other imaging tests, such as X-rays or MRIs.

While the system itself is new and undergoing testing, it employs imaging technology that has been used safely for many years. For specific questions, it is advisable to ask the study team for more details. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the StarGuide NextGen SPECT/CT system because it offers a cutting-edge approach to nuclear medicine imaging. Unlike traditional scanners, this new system is designed to provide higher resolution images, potentially leading to more accurate diagnoses. Additionally, it aims to improve the efficiency of imaging procedures, which could mean faster and more comfortable experiences for patients. This innovative technology could significantly enhance the quality of radiological assessments, making it a promising advancement in the field.

What evidence suggests that the StarGuide NextGen SPECT/CT system is effective for radiology?

Research has shown that the StarGuide NextGen SPECT/CT system, used in this trial, provides excellent image quality. Its high ability to distinguish different energy levels allows it to produce clearer images, especially with imaging agents like 99mTc and 177Lu. Studies suggest that this system can quickly scan the whole body, potentially leading to faster and more accurate diagnoses. This advanced imaging could aid in planning better treatments in the future. Overall, the StarGuide NextGen system shows promise in improving the accuracy of medical imaging. ^{2 6 7 8 9}

Who Is on the Research Team?

Carrie B. Hruska, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This clinical trial is open to individuals who meet specific criteria set by the researchers, which are not detailed in the provided information. To participate, one would need to fit these unspecified inclusion and exclusion criteria.

Inclusion Criteria

Able to provide consent for study participation StarGuide NextGen Evaluation

I am scheduled for a treatment or test using radioactive drugs.

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)

I am unable to give my consent to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo an additional scan for research purposes on the investigational StarGuide NextGen system

1 session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• StarGuide NextGen SPECT/CT system

Trial Overview The study is testing a new imaging system called StarGuide NextGen SPECT/CT. It's a pilot evaluation aimed at understanding how well this technology works and gathering data for its potential future use in clinical settings.

How Is the Trial Designed?

Group I: Nuclear medicine imaging Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

GE Healthcare

Industry Sponsor

Trials

307

Recruited

634,000+

Fotis Vlachos

GE Healthcare

Chief Marketing Officer since 2024

PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania

Peter J. Arduini

GE Healthcare

Chief Executive Officer since 2022

MBA from Northwestern University, BSc in Marketing from Susquehanna University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07272161

Pilot Evaluation of the StarGuide Next Generation SPECT ... The goal of this pilot study is to evaluate capabilities of the StarGuide NextGen SPECT/CT system to inform future clinical use of this ...

2. gehealthcare.com gehealthcare.com/products/molecular-imaging/starguide?srsltid=AfmBOoouafT1Dydd4F4NjEFnDZr3SGereyD7_EqluK_QPNBU04XqBBzM

Starguide Molecular Imaging - GE Healthcare StarGuide delivers a remarkable 5.9% energy resolution on 99mTc scans and 5% energy resolution on 177Lu (208 keV peak) scans. This superb energy resolution ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/65/supplement_2/242148

High Image Quality at Reduced Time per Bed Position – ... We have shown that fast whole-body post-therapy SPECT/CT is feasible using the StarGuide (GE Healthcare, Haifa, Israel), a next-generation multi ...

4. appliedradiology.com appliedradiology.com/articles/new-nuclear-medicine-system-designed-to-advance-precision-health-and-theranostics

New Nuclear Medicine System Designed to Advance ... GE Healthcare has unveiled StarGuide, the company's next-generation SPECT/CT system designed to help advance precision health and support greater theranostic ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10948674/

Comparison of a 3D CZT and conventional SPECT/CT system ... This study aimed to compare the dose assessment capabilities of a next-generation 3D CZT SPECT/CT (Veriton, Spectrum Dynamics) with those of a ...

6. gehealthcare.com gehealthcare.com/products/molecular-imaging/starguide?srsltid=AfmBOooPjuyU3TpKUO-8jBqH-gjVuNm5u-c40AOkZAIAx9WCHm5ETBFF

Starguide Molecular Imaging - GE Healthcare Introducing StarGuide, our most advanced SPECT/CT featuring advanced Cadmium Zinc Telluride (CZT) technology designed to usher in a new era of discovery for ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/K210173.pdf

GE Healthcare March 29, 2021 Mr. George Mashour ... The GE StarGuide system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient ...

8. techsciresearch.com techsciresearch.com/blog/product-review-ge-healthcare-starguide/184.html

Product Review: GE Healthcare StarGuide The improved SPECT resolution provides sharp images for enhanced visualization of anatomical details that can help physicians detect diseases at an early stage.

9. appliedradiationoncology.com appliedradiationoncology.com/articles/new-nuclear-medicine-system-designed-to-advance-precision-health-and-theranostics?returnUrl=%2Farticles%2Fnew-nuclear-medicine-system-designed-to-advance-precision-health-and-theranostics

New Nuclear Medicine System Designed to Advance ... In response, we designed our StarGuide SPECT/CT system to provide clinicians with the data they need to help them make personalized care ...