Fluciclovine (18F) Imaging of Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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An Open-labelled Study to Characterise Fluciclovine (18F) Uptake Measured by positRon emissiON Tomography In Breast cancER

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Fluciclovine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy proven breast cancer (invasive ductal or ductal carcinoma in situ (DCIS)) measuring ≥ 1.5cm Tumour size should be based on the longest diameter measured on ultrasound, mammogram or MRI performed within 2 months prior to enrolment. 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: Pregnant or breastfeeding women Major surgery or significant traumatic injury within four weeks prior to enrolment. Treatment with any other investigational agent, or participation in another interventional clinical study within 4 weeks prior to enrolment. Multifocal breast cancer (defined as more than two tumours, either unilateral or bilateral). Known hypersensitivity to fluciclovine (18F) or any of its constituents. Other psychological, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor study candidate or could interfere with protocol compliance or the interpretation of study results. Any other active malignancy or any previous diagnosis of melanoma.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluciclovine (18F) PET/CT<br> | Radiation: Fluciclovine<br>* Fluciclovine (18F) PET/CT scan completed >= 48 hours prior to surgical resection for breast cancer<br>* Other names: FACBC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | From tumour samples taken during standard of care surgery 48 hours or greater after PET/CT scan |