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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-12680 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2021-0768 | Other Identifier | M D Anderson Cancer Center | |
| R01CA258717 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Trevarx Biomedical, Inc | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment ([18F]FTT PET/CT) | Experimental | Patients receive [18F]FTT 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo [18F]FFT PET/CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lilie L Lilie | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siteman Cancer Center at Washington University | St Louis | Missouri | 63110 | United States | ||
| University of Pennsylvania/Abramson Cancer Center |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Fluorine F 18 Fluorthanatrace | Radiation | Given IV |
|
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| Positron Emission Tomography | Procedure | Undergo [18F]FFT PET/CT |
|
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| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |