Pilot Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution

May 26, 2026 updated by: Stanford University

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94304
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 18-F FDG Study using Breast-Dedicated PET Camera
Breast-Dedicated PET Camera will be used with standard PET 18-F FDG tracer dose
Drug: 18F-FDG
Participant will be injected IV (intravenously) with 10 ± 2 mCi of 18F-FDG.
Other Names:
  • 18F-fluorodeoxiglucose
  • 18F-FDG radiotracer
Device: Breast-dedicated PET camera
Breast-dedicated PET camera designed by Stanford satellite radiochemistry facility

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Image quality with the breast-dedicated PET camera
Time Frame: 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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Wendy B DeMartini, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

July 2, 2019

First Submitted That Met QC Criteria

July 10, 2019

First Posted (Actual)

July 12, 2019

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-50877 (Other Identifier: Stanford IRB)
  • BRS0102 (Other Identifier: OnCore)
  • NCI-2019-03810 (Registry Identifier: National Cancer Institute Clinical Trials Reporting Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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