Pilot Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution
Pilot Study of a Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution
2 other identifiers
interventional
20
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1 breast-cancer
Started Jun 2026
Shorter than P25 for early_phase_1 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2019
CompletedFirst Posted
Study publicly available on registry
July 12, 2019
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
Study Completion
Last participant's last visit for all outcomes
December 1, 2027
February 10, 2026
February 1, 2026
1.5 years
July 2, 2019
February 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Image quality with the breast-dedicated PET camera
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.
1 day
Study Arms (1)
18-F FDG Study using Breast-Dedicated PET Camera
EXPERIMENTALBreast-Dedicated PET Camera will be used with standard PET 18-F FDG tracer dose
Interventions
Participant will be injected IV (intravenously) with 10 ± 2 mCi of 18F-FDG.
Breast-dedicated PET camera designed by Stanford satellite radiochemistry facility
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \. Additional condition, or extenuating circumstance that, in the opinion of the investigator, may interfere with study compliance.
- Known allergies to FDG
- Pregnant or nursing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University
Stanford, California, 94304, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wendy B DeMartini
Stanford University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2019
First Posted
July 12, 2019
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
February 10, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share