Breast-Dedicated PET Camera for Breast Cancer

Overseen By Risa Jiron

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Stanford University

Disqualifiers: Allergies to FDG, Pregnant, others

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

Compensation: Varies

Number of Visits: 1

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a research study of a novel, "breast-dedicated" positron emission tomography (PET) camera with 1 millimeter spatial resolution. The main goal of the study is for the personnel to understand practical and logistical issues with using the camera in the clinic

Research Team

Wendy B DeMartini

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for individuals with biopsy-confirmed breast cancer that's at least 5 mm in size, as seen on mammogram or ultrasound. They must have had a recent imaging test within the last 60 days and be able to give informed consent. It's not open to those allergic to FDG, pregnant or nursing women, or anyone with conditions that could affect their participation.

Inclusion Criteria

My breast cancer is confirmed by biopsy and measures 5 mm or larger.

Prior diagnostic imaging test(s) with another modality such as MRI, CT, or x-ray mammography (or other applicable imaging modalities) within 60 days prior to the study date.

Documented written informed consent document.

Exclusion Criteria

Additional condition, or extenuating circumstance that, in the opinion of the investigator, may interfere with study compliance.

Pregnant or nursing.

Known allergies to FDG

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Participants undergo imaging using the breast-dedicated PET camera with standard PET 18-F FDG tracer dose

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

1-2 weeks

Treatment Details

Interventions

• 18F-FDG
• Breast-dedicated PET camera

Trial Overview The study is testing a new 'breast-dedicated' PET camera designed for high-resolution images of breast tissue using an imaging agent called 18F-FDG. The aim is to understand how well this technology works in a clinical setting and what practical issues might arise.

Participant Groups

Group I: 18-F FDG Study using Breast-Dedicated PET Camera Experimental Treatment 2 Interventions

Breast-Dedicated PET Camera will be used with standard PET 18-F FDG tracer dose

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+