Pilot Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution

NCT04016818 — Early Phase 1, Withdrawn, Stanford University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Pilot Study of a Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution

Registry	NCT04016818
Status	Withdrawn - Awaiting more funding to build a more stable technology.
Phase	Early Phase 1
Study type	Interventional; na, single group, masking: none, device feasibility
Sponsor	Stanford University (Other)
Conditions	Breast Cancer
Interventions	18F-FDG, Breast-dedicated PET camera (Drug, device)
Dates	start 2026-06-01 (estimated), primary completion 2027-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2019-07-12, last updated 2026-05-29
Locations	1 site in United States

-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

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
18-F FDG Study using Breast-Dedicated PET Camera	Experimental	Drug: 18F-FDG; Device: Breast-dedicated PET camera	Breast-Dedicated PET Camera will be used with standard PET 18-F FDG tracer dose

18F-FDG (Drug), also known as 18F-fluorodeoxiglucose, 18F-FDG radiotracer: Participant will be injected IV (intravenously) with 10 ± 2 mCi of 18F-FDG.
Breast-dedicated PET camera (Device): Breast-dedicated PET camera designed by Stanford satellite radiochemistry facility

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Stanford University	Stanford, California	United States

+Investigators

Wendy B DeMartini, Principal investigator, Stanford University