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Keep this study
Lead
M.D. Anderson Cancer Center
With
National Cancer Institute (NCI)
Trevarx Biomedical, Inc
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–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Participants will be \>= 18 years of age
Known primary breast cancer. For subjects with primary breast cancer we will target lesion size of 1.0 cm or greater on at least one type of standard clinical imaging (e.g. mammogram, ultrasound, breast magnetic resonance imaging \[MRI\])
A candidate for primary breast surgery (mastectomy or lumpectomy)
Participants must be informed of the investigational nature of this study and provide written informed consent, in accordance with institutional and federal guidelines prior to study-specific procedures
You may not be if
Females who are pregnant or breast feeding will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential prior to injection of FTT
Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
Current or prior therapy for the primary breast cancer
Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
Clareo Health | A Radiotracer ([18F]FluorThanatrace) by PET/CT for the Imaging of Breast Cancer
