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

This study has been completed.
Sponsor:
Collaborator:
Gamma Medica-Ideas
Information provided by (Responsible Party):
Deborah Rhodes, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00943527
First received: July 20, 2009
Last updated: January 23, 2012
Last verified: January 2012
History of Changes
  Purpose

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


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Molecular Breast Imaging: Effect of Menstrual Cycle, Hormone Therapy, and Tamoxifen on Tc-99m Sestamibi Uptake in the Breast.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Enrollment: 110
Study Start Date: January 2008
Study Completion Date: January 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   35 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Community Sample

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943527

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Gamma Medica-Ideas
  More Information

No publications provided

Responsible Party: Deborah Rhodes, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00943527     History of Changes
Other Study ID Numbers: 07-004850
Study First Received: July 20, 2009
Last Updated: January 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Breast
Menstrual Cycle
Breast Cancer
Hormone
 MBI
Molecular Breast Imaging
Breast Imaging

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013