Pilot Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04016818
• Other study ID #: IRB-50877
• Secondary ID: BRS0102IRB-50877
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: December 2024
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: Stanford University
• Contact: Risa Jiron
• Phone: 650-736-1598
• Email: rjiron[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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

Device:
• Breast-dedicated PET camera
Breast-dedicated PET camera designed by Stanford satellite radiochemistry facility

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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