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临床试验/NCT00943527
NCT00943527已完成不适用

Molecular Breast Imaging: Effect of Menstrual Cycle, Hormone Therapy, and Tamoxifen on Tc-99m Sestamibi Uptake in the Breast.

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
110
试验地点
1

研究概览

简要总结

This study is to examine the effects of menstrual cycle, hormone therapy, and the use of tamoxifen on Tc-99m sestamibi uptake.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
35 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • age 35-45
  • have regular menstrual cycles as defined by having menstrual cycle length of 25-31 days, with menstrual flow of 2-7 days, and no intermenstrual spotting or bleeding.
  • have had a negative screening mammogram within one year prior to the MBI studies that is available for comparison.

排除标准

  • currently using any exogenous hormones (e.g., hormonal contraceptives, sex steroid hormones) or any estrogen receptor modulating drugs (e.g., tamoxifen, raloxifene) or any aromatase inhibitors
  • have a personal history of any cancer, except non-melanomatous skin cancer
  • unable to understand and sign the consent form
  • pregnant or lactating
  • physically unable to sit upright and still for 30 minutes
  • Inclusion Criteria:
  • scheduled to begin one of the following regimens of HT:
  • Any dosage of any formulation of systemic estrogen therapy in the setting of a prior hysterectomy
  • Any dosage of continuous estrogen plus monthly, cyclic progesterone therapy where the progesterone therapy is the oral, micronized formulation
  • had a negative screening mammogram within one year prior to the MBI studies that is available for comparison.
  • Exclusion Criteria:
  • have a personal history of any cancer, except non-melanomatous skin cancer
  • unable to understand and sign the consent form
  • pregnant or lactating
  • physically unable to sit upright and still for 30 minutes
  • Inclusion Criteria:
  • scheduled to begin treatment with tamoxifen Or are currently being treated with tamoxifen (for > 1 month) and have had an MBI scan performed prior to its initiation
  • have had or will have the following test performed at Mayo Clinic: #87966, Cytochrome P450 2D6 genotyping for Tamoxifen Hormonal Therapy
  • have had a screening or diagnostic mammogram within one year of the MBI studies that is available for comparison.
  • Exclusion Criteria:
  • are using or have used any exogenous hormones (e.g., hormonal contraceptives, sex steroid hormones), any estrogen receptor modulating drugs other than tamoxifen, or any aromatase inhibitors from the time of 1 month prior to the first MBI until completion of the second MBI.
  • have been treated or will be undergoing treatment with systemic chemotherapy or external radiation beam therapy to the breast from the time of 6 months prior to the first MBI until the completion of the second MBI.
  • unable to understand and sign the consent form
  • pregnant or lactating
  • physically unable to sit upright and still for 30 minutes

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Deborah Rhodes

MD

Mayo Clinic

研究点 (1)

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