Somatostatin Receptor Imaging Study of Estrogen Receptor Positive (ER+) Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Uptake of Ga-68-DOTATATE or Copper-64 DOTATATE using Krenning Score and standardized uptake value (SUV)
研究概览
简要总结
This will be a Phase 2 clinical trial to assess somatostatin receptor (SSTR) expression in Stage IV estrogen receptor positive (ER+) breast cancer using Gallium-68 DOTATATE or Copper-64 DOTATATE PET/CT.
详细描述
Subjects with metastatic breast cancer are planned to be enrolled to undergo Gallium-68 DOTATATE or Copper-64 DOTATATE PET/CT imaging at one time point. SSTR uptake in metastatic lesions will be evaluated by independent central review (ICR). FDG PET and bone scans will also be performed within +/- 3 weeks of DOTATATE imaging.
The primary objective of this study is to evaluate uptake of Gallium-68 DOTATATE or Copper-64 DOTATATE in metastatic ER+ breast cancer lesions.
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
- 是
入选标准
- •Age of at least 18 years at the time of signing the informed consent.
- •Biopsy proven, ER+, HER2 any, clinically progressive, Stage IV breast cancer requiring restaging.
- •For women of childbearing potential (WOCBP):
- •a. Negative serum pregnancy test within 48 hours of Ga-68-DOTATATE injection. A women is considered to be of childbearing potential if she is post-menarchal, has not reached postmenopausal state (≥ 12 continuous months of amenorrhea [no menstrual bleeding of any kind, including menstrual period, irregular bleeding, spotting, etc.] with no identified cause other than menopause), and has not undergone surgical sterilization (total hysterectomy, or bilateral tubal ligation or bilateral oophorectomy at least 6 weeks before taking study drug).
- •Willingness and ability to provide written informed consent prior to any study-specific assessments and procedures commence.
排除标准
- •Known hypersensitivity to Gallium-68 DOTATATE or Copper-64 DOTATATE, octreotate, or any of the excipients of Gallium-68 DOTATATE or Copper-64 DOTATATE
- •Current high-dose glucocorticoid (≥ 20 mg prednisone daily or equivalent); long acting SSA within the last 28 days; short acting SSA that cannot be interrupted for 24 hours.
- •Unable to perform PET/CT scans according to technical specifications and local guidelines.
- •Concurrent primary malignancy, except adequately treated carcinoma in situ, non-melanoma carcinoma of the skin or any other curatively treated malignancy that has achieved complete response and is not expected to require treatment for recurrence during participation in the study.
- •Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
- •Unable or unwilling to comply with the requirements of the study protocol.
- •Prior participation in any interventional clinical study within 30 days prior to SSTR PET/CT scan.
结局指标
主要结局
Uptake of Ga-68-DOTATATE or Copper-64 DOTATATE using Krenning Score and standardized uptake value (SUV)
时间窗: 6 months
次要结局
未报告次要终点
研究者
Gary Ulaner
Director of Molecular Imaging and Therapy, Hoag Family Cancer Institute
Hoag Memorial Hospital Presbyterian