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


N/A
35 Years
45 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Authority:

United States: Institutional Review Board

Study ID:

07-004850

NCT ID:

NCT00943527

Start Date:

January 2008

Completion Date:

January 2012

Related Keywords:

  • Breast Cancer
  • Breast
  • Menstrual Cycle
  • Breast Cancer
  • Hormone
  • MBI
  • Molecular Breast Imaging
  • Breast Imaging
  • Breast Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905