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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00943527
• Other study ID #: 07-004850
• Status: Completed
• Phase: N/A
• First received: July 20, 2009
• Last updated: January 23, 2012
• Start date: January 2008
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 45 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Gamma Medica-Ideas

Country where clinical trial is conducted

United States,