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Imaging Using the Novel Radiotracer [18F] FluorThanaTrace([18F]FTT) by PET/CT in Patients With Breast Cancer
This phase II trial tests whether \[18F\]FluorThanatrace by positron emission tomography (PET)/computed tomography (CT) can improve imaging techniques in patients with breast cancer undergoing a standard of care biopsy or surgery. \[18F\]FluorThanatrace is a new radioactive tracer, which is a type of imaging agent that is labeled with a radioactive tag and injected into the body to help with imaging scans. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, \[18F\]FluorThanatrace. Because some cancers take up \[18F\]FluorThanatrace it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. \[18F\]FluorThanatrace by PET/CT may help detect the activity of a certain enzyme in the body that may be related to cancer growth in patients with breast cancer.
PRIMARY OBJECTIVE: I. Correlate \[18F\]FluorThanatrace (FTT) PET/CT uptake in patients with primary breast cancer compared to PARP1 quantitative immunohistochemistry (IHC) as the tissue reference standard. SECONDARY OBJECTIVES: I. Correlate \[18F\]FluorThanatrace uptake with other measures of PARP-1 activity in tumor tissue samples - quantitative IHC, immunofluorescence (IF) and \[125I\]KX1 autoradiography. II. Determine the ranges of uptake on \[18F\]FluorThanatrace PET/CT imaging across patients with breast cancer undergoing \[18F\]FTT PET/CT. III. Demonstrate the reproducibility of \[18F\]FTT uptake on PET/CT using test-retest imaging. IV. Confirm the safety of \[18F\]FluorThanatrace. OUTLINE: Patients receive \[18F\]FTT intravenously (IV) over a few seconds to a minute and then undergo PET/CT scan over 20-30 minutes at baseline and another optional scan 1 week later. During the \[18F\]FTT PET/CT scan patients.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Siteman Cancer Center at Washington University
St Louis, Missouri, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
M D Anderson Cancer Center
Houston, Texas, United States
Start Date
February 27, 2023
Primary Completion Date
August 20, 2026
Completion Date
August 20, 2026
Last Updated
December 15, 2025
36
ESTIMATED participants
Computed Tomography
PROCEDURE
Fluorine F 18 Fluorthanatrace
RADIATION
Positron Emission Tomography
PROCEDURE
Lead Sponsor
M.D. Anderson Cancer Center
Collaborators
NCT05673200
NCT04704661
Data Source & Attribution
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