Evaluation of Somatostatin Receptor Expression in PET 68Ga-DOTATOC in Patients Followed for Metastatic Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Presence of lesions expressing SST2 receptors in 68Ga-DOTATOC in patients followed for metastatic breast cancer
研究概览
简要总结
DOTABREAST: Evaluation of Somatostatin Receptor Expression in PET 68Ga-DOTATOC in Patients Followed for Metastatic Breast Cancer
This is a prospective, monocentric, non-controlled, non-randomized, open-label, interventional study.
详细描述
In women, breast cancer is the 1st largest cancer and accounted for 31% of new cancer cases in women in 2017. With 11,913 deaths in 2015, breast cancer is the 1st largest cancer death in women (19%) and the 3rd largest cancer death (men and women included) after lung and colorectal cancer. At initial diagnosis at any stage, approximately 31% of patients have regional lymph node involvement and 5 to 10% present metastatic involvement from the outset. Progression to a metastatic form occurs in about 20% of cases. The risk of metastatic evolution is variable depending on the histological subtype and is a major prognostic event directly impacting overall survival. DOTATOC-68Ga PET scans allows in vivo evaluation of SST2 somatostatin receptor expression. Its use is widely validated in clinical practice for the assessment of extension of neuroendocrine tumors. It is also being used to evaluate the feasibility of SST2-targeted internal radiotherapy therapy with Lutathera (177Lu-Oxodotreotide) in patients with metastatic small intestine neuroendocrine tumours.
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 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age over 18
- •Patients with metastatic breast cancer who have completed at least one first line of systemic therapy for metastatic breast cancer
- •Patient labeled on the primary lesion ER+HER2- (20)
- •Presence of metastatic liver and bone lesions identifiable with 18F-FDG PET-Scan
- •Presence of at least 10 identifiable secondary lesions in 18F-FDG PET-Scan
- •No therapeutic change between 18F-FDG PET-Scan and 68Ga-DOTATOC PET-Scan.
- •Performing the PET scan with 68Ga-DOTATOC within a maximum of 21 days after the 18F-FDG PET-Scan
- •Person affiliated to or benefiting from social security
- •Person who has given written informed consent
排除标准
- •Patients followed or with history of other active neoplastic pathology (including neuroendocrine tumor)
- •Known allergy to 68Ga-DOTATOC or its excipients
- •Subject refusing to sign the consent to participate
- •Minor subject
- •Subject excluded from another study
- •Persons referred to Articles L1121-5 to L1121-8 of the Public Health Code (CSP)
- •Subject cannot be contacted in case of emergency
研究组 & 干预措施
Performing a 68Ga-Dotatoc PET scan in patients followed for metastatic breast cancer.
- Prescreening of the patient followed for metastatic breast cancer during the routine care
- V1 Selection: Patient's selection in the Nuclear Medicin or Oncology department
- V2 Inclusion: The day of the 68Ga-Dotatoc PET scan in the Nuclear Medicin department
- V3 End of study visit, the same day after the 68Ga-Dotatoc PET scan.
干预措施: 68Ga-DOTATOC (Drug)
结局指标
主要结局
Presence of lesions expressing SST2 receptors in 68Ga-DOTATOC in patients followed for metastatic breast cancer
时间窗: Baseline (during the PET examination)
Krenning Score \>2
次要结局
- Distribution of SST2 receptor overexpression by 68Ga-DOTATOC PET compared to 18F-FDG PET lesions.(Baseline (during the PET examination))
- Disease proportion with SST2 receptor overexpression by 68Ga-DOTATOC PET compared to known metastatic disease by 18F-FDG PET(Baseline (during the PET examination))
- Expression of SST2 receptors of lesions as a function of different metastatic sites, via the Krenning score(Baseline (during the PET examination))
- Expression of SST2 receptors of lesions as a function of different metastatic sites, via the PET quantification parameters.(Baseline (during the PET examination))
- Correlation between the metabolic activity of 18F-FDG PET lesions and the expression of SST2 receptors in 68Ga-DOTATOC PET per lesion and per patient.(Baseline (during the PET examination))
- Clinica predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient(Baseline (during the PET examination))
- Biological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient(Baseline (during the PET examination))
- Histological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient(Baseline (during the PET examination))
- Imaging predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET per patient(Baseline (during the PET examination))
- Clinical predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion(Baseline (during the PET examination))
- Biological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion(Baseline (during the PET examination))
- Histological predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion(Baseline (during the PET examination))
- Imaging predictors of overexpression of SST2 receptors in 68Ga-DOTATOC PET by lesion(Baseline (during the PET examination))