Breast Cancer
Conditions
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.
Interventions
DRUG18F-FDG
Participant will be injected IV (intravenously) with 10 ± 2 mCi of 18F-FDG.
DEVICEBreast-dedicated PET camera
Breast-dedicated PET camera designed by Stanford satellite radiochemistry facility
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWendy B DeMartini
Stanford University
Outcome results
None listed