Pilot Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution

NCT ID: NCT04016818

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-12-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

18-F FDG Study using Breast-Dedicated PET Camera

Breast-Dedicated PET Camera will be used with standard PET 18-F FDG tracer dose

Group Type: EXPERIMENTAL

18F-FDG

Intervention Type: DRUG

Participant will be injected IV (intravenously) with 10 ± 2 mCi of 18F-FDG.

Breast-dedicated PET camera

Intervention Type: DEVICE

Breast-dedicated PET camera designed by Stanford satellite radiochemistry facility

Interventions

18F-FDG

Participant will be injected IV (intravenously) with 10 ± 2 mCi of 18F-FDG.

Intervention Type: DRUG

Breast-dedicated PET camera

Breast-dedicated PET camera designed by Stanford satellite radiochemistry facility

Intervention Type: DEVICE

Other Intervention Names

18F-fluorodeoxiglucose; 18F-FDG radiotracer

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wendy B DeMartini

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

Central Contacts

Risa Jiron

Role: CONTACT

rjiron@stanford.edu

650-736-1598

Facility Contacts

Risa Jiron

Role: primary

rjiron@stanford.edu

650-736-1598

Other Identifiers

BRS0102

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-50877

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-50877

Identifier Type: -

Identifier Source: org_study_id