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临床试验/NCT00647790
NCT00647790已完成不适用

PET Using Hormone Receptor Ligands in Breast Cancer

Memorial Sloan Kettering Cancer Center1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2006年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
79
试验地点
1
主要终点
To use estrogen-like ligands labeled with positron emitters to preoperatively evaluate the estrogen receptor (ER) status of breast cancer on PET imaging.

研究概览

简要总结

The purpose of this study is to find a way to learn the hormone receptor status of a tumor before surgery is done. By testing for the hormone receptor proteins, doctors can find out if the breast cancer uses hormones to grow. This is important since the hormone receptor status of a tumor helps doctors decide if extra treatment like chemotherapy or pills are needed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and Female patients
  • Aged 18 or older at the time of breast cancer diagnosis
  • Patients with invasive breast cancer at least 1 cm in size. Patients who have had a prior surgical excision are eligible provided there is a residual of at least a 1 cm area suspected on imaging studies.
  • Histopathologic review at MSKCC confirming diagnosis of invasive breast cancer (ductal, lobular, or inflammatory breast cancer).
  • Patients who are operative candidates. Patient will have surgery to include either mastectomy or lumpectomy. Radiologic assisted excisions such as needle localization are also eligible.
  • Patients with bilateral breast cancer are eligible.
  • Patients with metastatic cancer, provided they need surgical biopsy.
  • Patients who are undergoing sentinel node mapping (day before or sameday mapping).
  • Patient must sign informed consent.

排除标准

  • Previous or concurrent malignancy (except basal and squamous skin cancer and stage 0 cervical cancer)
  • Patients who are pregnant or nursing
  • Patients unable to tolerate PET or PET/CT
  • Patients with known active infection, autoimmune or inflammatory disease such as sarcoidosis, and rheumatoid arthritis.
  • Patients with non invasive breast cancer such as DCIS.
  • Patients who have received prior radiation therapy to the affected breast.
  • Patients who have received prior chemotherapy, including neoadjuvant chemotherapy or hormonal therapy for breast cancer.
  • Patients living in a residential care or correctional facility.

结局指标

主要结局

To use estrogen-like ligands labeled with positron emitters to preoperatively evaluate the estrogen receptor (ER) status of breast cancer on PET imaging.

时间窗: conclusion of the study

次要结局

  • To correlate ER positivity on PET ligand imaging, and conventional immunohistochemical pathologic analysis of ER positivity in surgical specimens.(conclusion of the study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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