NCT03036943已完成不适用
An Open-labelled Study to Characterise Fluciclovine (18F) Uptake Measured by positRon emissiON Tomography In Breast cancER
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Tumour standardised uptake values (SUV) in invasive breast cancer, classified by molecular type, on fluciclovine (18F) PET imaging.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Tumour standardised uptake values (SUV) in invasive breast cancer, classified by molecular type, on fluciclovine (18F) PET imaging.
时间窗: From PET/CT scan commencing approx 30 seconds after fluciclovine (18F) administration
次要结局
- 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)
研究者
研究点 (2)
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