2024-512465-14-00招募中2 期
18F-FES PET/MRI for tailoring treatment of luminal A and lobular breast cancer: a phase II trial evaluating the performance of FES PET/MRI in axillary staging
Universita' Vita-salute S. Raffaele1 个研究点 分布在 1 个国家目标入组 221 人开始时间: 2024年7月4日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 221
- 试验地点
- 1
- 主要终点
- Sensitivity (SE) of FES PET/MRI and axillary ultrasound (US) to detect macrometastatic (tumor deposit>2mm) axillary lymph nodes with the goal of demonstrating the superiority of FES PET/MRI over US.
研究概览
简要总结
To compare the sensitivity of FES PET/MRI versus axillary ultrasound (US) in detecting macrometastatic lymph nodes (tumor deposit >2mm) in the axilla of BC patients with LumA or Lob who are candidates for axillary surgery for primary surgery.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients aged ≥18 years;
- •Able to autonomously sign the informed consent.
- •Patients with diagnosis of LumA or ER-positive Lob;
- •Candidates to surgery as first treatment regardless of clinical nodal (cN) status.
- •Normal hepatic and renal function
- •Women of Child-Bearing Potential (WOCBP, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile for hysterectomy, bilateral salpingectomy and bilateral oophorectomy) accepting to use highly effective contraceptive measures for the whole duration of the trial (i.e. Intrauterine device with no hormone releasing system, sexual abstinence, in case of tubal ligation or partner undergone vasectomy, condom with or without spermicide, cap, diaphragm or sponge with spermicide).
- •Translational group • Patients with large (>2cm) tumors with heterogeneity on imaging (FES uptake unevenly distributed within the same or multiple lesion) or/and final pathology (presence of different cell populations or histotypes within the same or multiple lesions).
排除标准
- •ER-negative tumors;
- •Translational group • No sign of heterogeneity on imaging or final pathology • No availability of sufficient tissue samples for analyses
- •Metastatic patients.
- •Breast-feeding women;
- •Women on low-sodium diet;
- •History of epilepsy
- •Current assumption of ER-antagonists (i.e. tamoxifen suspended less than 8 weeks before or fulvestrant suspended less than 28 weeks before the exam)
- •Contraindications to PET (i.e. uncontrolled diabetes);
- •Contraindications to MRI (i.e. Claustrophobia, Allergy to the MR contrast agent, Severe renal insufficiency, pacemaker);
研究组 & 干预措施
-
Experimental
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Sensitivity (SE) of FES PET/MRI and axillary ultrasound (US) to detect macrometastatic (tumor deposit>2mm) axillary lymph nodes with the goal of demonstrating the superiority of FES PET/MRI over US.
Sensitivity (SE) of FES PET/MRI and axillary ultrasound (US) to detect macrometastatic (tumor deposit>2mm) axillary lymph nodes with the goal of demonstrating the superiority of FES PET/MRI over US.
次要结局
- Specificity, positive predictive value, negative predictive value, and overall accuracy of FES PET/MRI.
- Comparison FES PET/MRI vs standard imaging. Results from FES PET/MRI will be compared with standard imaging in terms of sensitivity and number of lesions with FES uptake versus previously known lesions from all preoperative exams (mammography, ultrasound or any exam performed as preoperative routine).
- Correlation between recurrence score and FES PET/MRI findings and parameters will be investigated. This analysis will include a subset of patients for whom Oncotype DX will be performed after surgery according to standard indications. The recurrence score will be correlated to the quantitative imaging PET parameters (SUVmax, SUVmean, MTV, TLG).
研究者
Clinical Trial Center - Trial Startup Unit
Scientific
Universita' Vita-salute S. Raffaele
研究点 (1)
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