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

NCT00943527 | Completed

• 1 other identifier: 07-004850
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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

Keywords

Breast; Menstrual Cycle; Breast Cancer; Hormone; MBI; Molecular Breast Imaging; Breast Imaging

Study Arms (3)

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.

2

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

3

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

Eligibility Criteria

• Age: 35 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Community Sample

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Gamma Medica-Ideas: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 20, 2009
• First Posted: July 22, 2009
• Study Start: January 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2012
• Last Updated: January 25, 2012

Record last verified: 2012-01

Locations

US (1)