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

NCT ID: NCT00943527

Last Updated: 2012-01-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-01-31

Brief Summary

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

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

1

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.

No interventions assigned to this group

2

Women Initiating Hormone Therapy and have had a negative mammogram preformed at the Mayo Clinic Rochester within the last year.

No interventions assigned to this group

3

Women Initiating Tamoxifen who have had a negative mammogram preformed at the Mayo Clinic Rochester.

No interventions assigned to this group

Eligibility Criteria

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.

• 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.

• 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

• 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

• 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

• 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Gamma Medica-Ideas

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Deborah Rhodes

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

07-004850

Identifier Type: -

Identifier Source: org_study_id