Breast Carcinoma Clinical Trial
Official title:
Imaging Using the Novel Radiotracer [18F] FluorThanaTrace([18F]FTT) by PET/CT in Patients With Breast Cancer
Verified date | June 2024 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 36 |
Est. completion date | August 20, 2026 |
Est. primary completion date | August 20, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
United States | University of Pennsylvania/Abramson Cancer Center | Philadelphia | Pennsylvania |
United States | Siteman Cancer Center at Washington University | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI), Trevarx Biomedical, Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation of [18F]FluorThanatrace (FTT) uptake with PARP expression | The primary breast cancer tumor site is determined by standardized uptake values (SUV) based quantitative measures and PARP is measured by PARP1 mmunohistochemistry (IHC). This will be summarized as mean and standard deviation across patients. | through study completion, an average of 1 year |
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