Clinical trial NCT00943527: Hormonal Effects on Tc-99m Sestamibi Uptake in the Breast
Official title: Molecular Breast Imaging: Effect of Menstrual Cycle, Hormone Therapy, and Tamoxifen on Tc-99m Sestamibi Uptake in the Breast.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast
Menstrual Cycle
Breast Cancer
Hormone
MBI
Molecular Breast Imaging
Breast Imaging
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Gamma Medica-Ideas
First posted: 2009-07-22
Enrollment: 110
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community Sample

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


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References: