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Pilot Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04016818
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
17
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
Pilot Study of a Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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 Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University Stanford California United States 94304

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Wendy B DeMartini, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stanford University
    ClinicalTrials.gov Identifier:
    NCT04016818
    Other Study ID Numbers:
    • IRB-50877
    • BRS0102
    • IRB-50877
    First Posted:
    Jul 12, 2019
    Last Update Posted:
    Jun 13, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Fluorodeoxyglucose F18

    Study Results

    No Results Posted as of Jun 13, 2022