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Pilot Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution

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ClinicalTrials.gov Identifier: NCT04016818
Recruitment Status : Not yet recruiting
First Posted : July 12, 2019
Last Update Posted : August 21, 2020
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Description
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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
Breast Cancer Drug: 18F-FDG Device: Breast-dedicated PET camera 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016818


Contacts
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Contact: Risa Jiron 650-736-1598 rjiron@stanford.edu

Locations
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United States, California
Stanford University
Stanford, California, United States, 94304
Contact: Risa Jiron    650-736-1598    rjiron@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Wendy B DeMartini Stanford University
More Information
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04016818    
Other Study ID Numbers: IRB-50877
BRS0102 ( Other Identifier: OnCore )
IRB-50877 ( Other Identifier: Stanford IRB )
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action