Status:
ACTIVE_NOT_RECRUITING
A Radiotracer ([18F]FluorThanatrace) by PET/CT for the Imaging of Breast Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Trevarx Biomedical, Inc
Conditions:
Breast Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 stand...
Detailed Description
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 sta...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 20 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05226663
Start Date
February 27 2023
End Date
August 20 2026
Last Update
December 15 2025
Active Locations (3)
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1
Siteman Cancer Center at Washington University
St Louis, Missouri, United States, 63110
2
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
3
M D Anderson Cancer Center
Houston, Texas, United States, 77030