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Completed

NCT Number: NCT00943527

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

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

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Key information

Age range

35 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Gamma Medica-Ideas

Registry information

Official study title

Molecular Breast Imaging: Effect of Menstrual Cycle, Hormone Therapy, and Tamoxifen on Tc-99m Sestamibi Uptake in the Breast.

Important dates

Study start
2008
Primary completion
2010
Study completion
2012
First posted
Jul 22, 2009
Registry last updated
Jan 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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