Pilot Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution

Stanford University

Status and phase

Not yet enrolling

Early Phase 1

Conditions

Breast Cancer

Treatments

Device: Breast-dedicated PET camera

Drug: 18F-FDG

Study type

Interventional

Funder types

Other

Identifiers

NCT04016818

BRS0102 (Other Identifier)

IRB-50877 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.