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| Name | Class |
|---|---|
| Blue Earth Diagnostics | INDUSTRY |
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The purpose of this study is to find out what a new amino acid-based PET agent, fluciclovine (18F), can tell us about breast cancer biology (how it grows and develops), and quantify the differences in fluciclovine (18F) uptake between breast cancer subtypes. This will inform further work to investigate its use in breast cancer management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluciclovine (18F) PET/CT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluciclovine | Radiation | Fluciclovine (18F) PET/CT scan completed >= 48 hours prior to surgical resection for breast cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumour standardised uptake values (SUV) in invasive breast cancer, classified by molecular type, on fluciclovine (18F) PET imaging. | From PET/CT scan commencing approx 30 seconds after fluciclovine (18F) administration |
| Measure | Description | Time Frame |
|---|---|---|
| Amino acid transporter (AAT) and related growth pathway expression levels quantitatively assessed by immunohistochemistry using the H-score method, and correlated to fluciclovine (18F) uptake (SUV). | From tumour samples taken during standard of care surgery 48 hours or greater after PET/CT scan | |
| Tumour metabolite levels characterized by fold change compared to metabolite levels in the adjacent normal tissue, and correlated to fluciclovine (18F) uptake. |
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Inclusion Criteria:
Biopsy proven breast cancer (invasive ductal or ductal carcinoma in situ (DCIS)) measuring ≥ 1.5cm
No prior treatment for breast cancer.
Female, Age >= 40 years.
The patient is willing and able to comply with the protocol scheduled visits and examinations for the duration of the study. Women of childbearing potential must follow contraception guidance given as standard of care at breast cancer diagnosis.
Written (signed and dated) informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Harris, Prof | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Churchill Hospital | Oxford | OX3 7LE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34795409 | Derived | Scott NP, Teoh EJ, Flight H, Jones BE, Niederer J, Mustata L, MacLean GM, Roy PG, Remoundos DD, Snell C, Liu C, Gleeson FV, Harris AL, Lord SR, McGowan DR. Characterising 18F-fluciclovine uptake in breast cancer through the use of dynamic PET/CT imaging. Br J Cancer. 2022 Mar;126(4):598-605. doi: 10.1038/s41416-021-01623-3. Epub 2021 Nov 18. |
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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 |
|---|---|
| C117460 | fluciclovine F-18 |
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| From tumour samples taken during standard of care surgery 48 hours or greater after PET/CT scan |
| D017437 |
| Skin and Connective Tissue Diseases |