Clinical trial · Observational
Hormonal Effects on Tc-99m Sestamibi Uptake in the Breast
Molecular Breast Imaging: Effect of Menstrual Cycle, Hormone Therapy, and Tamoxifen on Tc-99m Sestamibi Uptake in the Breast.
NCT00943527CI-TRIAL-00006131completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to examine the effects of menstrual cycle, hormone therapy, and the use of tamoxifen on Tc-99m sestamibi uptake.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- 1
- description
- 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.
- label
- 2
- description
- Women Initiating Hormone Therapy and have had a negative mammogram preformed at the Mayo Clinic Rochester within the last year.
- label
- 3
- description
- Women Initiating Tamoxifen who have had a negative mammogram preformed at the Mayo Clinic Rochester.
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.