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Histology of Functional Density in Postmenopausal Breast

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Carrie Hruska, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01240278
First received: November 5, 2010
Last updated: April 10, 2014
Last verified: April 2014

November 5, 2010
April 10, 2014
November 2010
October 2014   (final data collection date for primary outcome measure)
proportion of epithelium vs stroma [ Time Frame: within 1 month of functional density assessment on MBI ] [ Designated as safety issue: No ]
Relative composition of epithelium vs stroma [ Time Frame: within 1 month of functional density assessment on MBI ] [ Designated as safety issue: No ]
The relative composition of epithelium vs stroma in dense tissue which appears photopenic on MBI will be compared to that of dense tissue which appears functionally active on MBI.
Complete list of historical versions of study NCT01240278 on ClinicalTrials.gov Archive Site
  • Degree of lobular involution [ Time Frame: within 1 month of functional density assessment on MBI ] [ Designated as safety issue: No ]
    Degree of lobular involution as assessed through qualitative and quantitative measurements will be compared between dense tissue which appears photopenic on MBI and dense tissue which appears functionally active on MBI.
  • Ki-67 cellular proliferation index [ Time Frame: within 1 month of functional density assessment on MBI ] [ Designated as safety issue: No ]
    Degree of cellular proliferation as assessed through Ki-67 index will be compared between dense tissue which appears photopenic on MBI and dense tissue which appears functionally active on MBI.
Same as current
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Histology of Functional Density in Postmenopausal Breast
Pilot Study to Examine Histological Characteristics of Mammographic Density With Molecular Breast Imaging: Part 1 - Postmenopausal Women

Increased mammographic density is recognized as an important risk factor for developing breast cancer, however, the underlying mechanism explaining this relationship is unclear. The investigators hypothesize that Molecular Breast Imaging (MBI) can more accurately distinguish dense tissue on mammography which is at high risk from dense tissue at low risk by indicating cellular activity in dense tissue as radiotracer uptake (functional density) in the breast. In this pilot study, the investigators want to compare the histological characteristics of breast tissue in patients with who have similar density on mammography but different levels of functional density on MBI.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

core biopsy samples of dense breast tissue

Non-Probability Sample

Women with mammographically dense breasts who demonstrate either photopenic or marked background parenchymal uptake on MBI.

  • Dense Breasts
  • Breast Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
20
December 2014
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 40 or older
  2. Be postmenopausal as defined as having at least 12 consecutive months of amenorrhea
  3. Screening mammogram performed at Mayo Clinic Rochester within one year prior to the current MBI study which demonstrates

    1. Negative or benign assessment (BIRADs category 1-2)
    2. No proliferative benign lesions (e.g. fibroadenomas) identified
    3. Heterogeneously dense or extremely dense parenchyma (BIRADs density category 3 or 4)
  4. MBI performed less than one month prior to biopsy demonstrating either significant FD or photopenic FD.

Exclusion criteria:

  1. 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 within six months prior to study biopsy.
  2. Personal history of any cancer, except non-melanomatous skin cancer
  3. Current breast symptoms
  4. Breast implants
  5. Known allergy to local anesthetic.
  6. History of bleeding complications from prior interventions
  7. Current use of anticoagulants (e.g., Coumadin or other blood thinners)
  8. Major medical condition
Female
40 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01240278
10-004506
No
Carrie Hruska, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Carrie Hruska, PhD Mayo Clinic
Mayo Clinic
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP