Hormonal Effects on Tc-99m Sestamibi Uptake in the Breast

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

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

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Arm 1 Inclusion Criteria: 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. Exclusion Criteria: 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 Arm 2 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 Arm 3 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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Premenopausal Women who are not taking hormones or birth control. Ages 35-45 who have had a negative mammograph performed at the Mayo Clinic in Rochester within the last year. | |
| 2<br>Women Initiating Hormone Therapy and have had a negative mammogram preformed at the Mayo Clinic Rochester within the last year. | |
| 3<br>Women Initiating Tamoxifen who have had a negative mammogram preformed at the Mayo Clinic Rochester. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast, Menstrual Cycle, Breast Cancer, Hormone, MBI, Molecular Breast Imaging, Breast Imaging