Pilot Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution

Early Phase 1

Not yet recruiting

• Conditions: Breast Cancer
• Interventions: Drug: 18F-FDG; Device: Breast-dedicated PET camera

• Registration Number: NCT04016818
• Lead Sponsor: Stanford University

Brief Summary

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

Detailed Description

Primary Objective To obtain initial experience using the novel, breast-dedicated PET camera design in the breast imaging clinic.

Secondary Objectives To understand, given the 10-fold higher sensitivity of this novel camera, how low we can go with administered tracer dose, and, given the \>100-fold better volumetric spatial resolution, understand the achievable image quality.

Study Timeline

• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-10
• Study First Posted: 2019-07-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-24
• Study Start: 2026-01
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Biopsy-confirmed breast cancer measuring ≥ 5 mm on mammogram or ultrasound.
• 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

• 1. Additional condition, or extenuating circumstance that, in the opinion of the investigator, may interfere with study compliance.
• Known allergies to FDG
• Pregnant or nursing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18-F FDG Study using Breast-Dedicated PET Camera	18F-FDG	Breast-Dedicated PET Camera will be used with standard PET 18-F FDG tracer dose
18-F FDG Study using Breast-Dedicated PET Camera	Breast-dedicated PET camera	Breast-Dedicated PET Camera will be used with standard PET 18-F FDG tracer dose

Primary Outcome Measures

Name	Time	Method
Image quality with the breast-dedicated PET camera	1 day	Feasibility of the pilot breast-dedicated PET camera will be assessed on the basis of whether acceptable images are obtained. Images will be assessed and graded as 1 of 3 quality ratings: excellent, good, and poor. The outcome will be reported as the number of images that are excellent, good, and poor, a number without dispersion.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States