Pilot Feasibility Study: Inflammation and Presence of M2 Macrophages Explorations With[18F]-DPA-714 PET/CT in Triple Negative Breast Cancers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 3
- 主要终点
- Correlation between M1/M2 macrophage polarization and [18F]DPA-714 PET/CT binding
研究概览
简要总结
This phase II study is assessing the correlation between M1/M2 macrophage polarization determined by tumor immunohistochemistry analysis and [18F]DPA-714 PET/CT binding (qualitative and texture analysis) in patients with operable triple negative breast cancer.
详细描述
The purpose of this study is to evaluate the correlation of inflammation assessed by M1/M2 macrophage polarization determined by tumor immunohistochemistry analysis and [18F] DPA-714 PET imaging by using qualitative and image texture analysis in patients with triple negative breast cancer.
Patients receive pre-therapeutic diffusion-weighted breast MRI (Magnetic resonance imaging) and 18FDG (fluorodeoxyglucose) PET/CT (Positron Emission Tomography/Computerized Tomography) scan within 30 days before enrollment.
[18F] DPA-714 PET/CT scan is performed before surgery. About 3 MBq/Kg of [18F] DPA-714 are injected intravenously, two acquisition sequences are performed following injection and 60 minutes after injection in order to evaluate early and late tumor uptake of [18F] DPA-714.
Surgery is scheduled after [18F] DPA-714 PET/CT scan. Tissue samples from breast surgery are used to assess M1 and M2 macrophages expression and to perform tumor molecular subtyping by Immunohistochemical analysis. Tumor Autoradiography with the TSPO (18 kDa Translocator Protein) ligand [18F]DPA-714 will be also assessed on tumor tissue.
A blood sample is performed before [18F] DPA-714 PET/CT scan in order to assess the genotyping of TSPO (18 kDa Translocator Protein) gene.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 Years and older
- •Triple negative primary breast cancer based on immunohistochemical results as follows:
- •Estrogen receptor < 10%
- •And Progesterone receptors < 10%
- •And HER2 (Human Epidermal Growth Factor Receptor-2) not amplified or not overexpressed
- •Patient with a primary tumor eligible for primary surgery
- •Performance Status equal to 0 or 1
- •Fertile patients must use effective contraception
- •Patient must be affiliated to a Social Health Insurance
- •Written informed consent
排除标准
- •Patient with No triple negative breast cancer
- •Patient with inflammatory breast cancer
- •Patient with metastatic breast cancer
- •Patient receiving cancer treatments such as chemotherapy, immunotherapy, biologic response modifiers, hormonal therapy, and radiotherapy BEFORE the biopsy and PET scans are performed
- •Treated diabetes with fasting blood glucose > 10 mmol/L
- •Patient who received antibiotics and/or steroidal and/or non-steroidal anti-inflammatory drugs within 30 days PRIOR to [18F]-DPA-714 PET scan
- •Contraindication to MRI (implants or metallic prosthesis, severe claustrophobia, pacemaker ...)
- •Patient deprived of liberty, under a measure of safeguard of justice, under guardianship or under the authority of a guardian
- •Pregnant or nursing patient
- •Agitation; impossibility of lying motionless for at least 1 hour, or known claustrophobia
研究组 & 干预措施
[18F]-DPA-714
pretherapeutic [18F]-DPA-714 PET/CT scan
干预措施: [18F]-DPA-714 PET/CT scan (Drug)
结局指标
主要结局
Correlation between M1/M2 macrophage polarization and [18F]DPA-714 PET/CT binding
时间窗: 18 months
M1/M2 macrophage polarization will be assessed by tumor immunohistochemistry analysis, \[18F\]DPA-714 PET/CT binding will be assessed by qualitative and images texture analysis
次要结局
- Assess the value of early and late [18F]-DPA-714 PET/CT acquisitions(18 months)
- Evaluate the performance of the three types of imaging used in this study: [18F]-DPA-714 PET/CT (early and late), 18FDG PET/CT and diffusion-weighted breast MRI in the characterization of triple negative breast cancer(18 months)
- Correlation between TSPO genotyping (HAB = High Affinity Binder, MAB = Mixed Affinity Binder and LAB = Low Affinity Binder) and [18F]DPA-714 PET/CT binding(18 months)
- Perform tumor molecular subtyping(18 months)
- [18F]-DPA-714 toxicity(18 months)