Dense BreastsNCT01240278
Histology of Functional Density in Postmenopausal Breast
An observational study of Dense Breasts and Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dense Breasts, Breast Cancer
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to 27 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with mammographically dense breasts who demonstrate either photopenic or marked background parenchymal uptake on MBI.
Who may be able to join
- Age 40 or older
- Be postmenopausal as defined as having at least 12 consecutive months of amenorrhea
- Screening mammogram performed at Mayo Clinic Rochester within one year prior to the current MBI study which demonstrates
- Negative or benign assessment (BIRADs category 1-2)
- No proliferative benign lesions (e.g. fibroadenomas) identified
- Heterogeneously dense or extremely dense parenchyma (BIRADs density category 3 or 4)
- MBI performed less than one month prior to biopsy demonstrating either significant FD or photopenic FD.
Who cannot join
- 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.
- Personal history of any cancer, except non-melanomatous skin cancer
- Current breast symptoms
- Breast implants
- Known allergy to local anesthetic.
- History of bleeding complications from prior interventions
- Current use of anticoagulants (e.g., Coumadin or other blood thinners)
- Major medical condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
- Conditions
- Dense Breasts, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of epithelium vs stroma
Measured: within 1 month of functional density assessment on MBI
Secondary outcomes (2)
Degree of lobular involution
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.
Measured: within 1 month of functional density assessment on MBI
Ki-67 cellular proliferation index
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.
Measured: within 1 month of functional density assessment on MBI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startNov 2010
- Primary completion27 Apr 2022
- Study completion27 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dense BreastsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carrie Hruska, Mayo Clinic
- Investigators
- Carrie Hruska, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240278
- Sponsor's protocol ID
- 10-004506
- Status last verified
- Jul 2022
- First submitted
- 5 Nov 2010
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bardwell Speltz L, Ghosh K, Visscher DW, Scott CG, Cole KC, Kroneman TN, Maxwell RW, Conners AL, Hunt KN, Rhodes DJ, Vachon CM, Hruska CB. Histologic correlates of background parenchymal uptake on molecular breast imaging. Breast Cancer Res. 2025 Dec 16;27(1):216. doi: 10.1186/s13058-025-02171-x.
PubMed 41402965
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Examine Histological Characteristics of Mammographic Density With Molecular Breast Imaging: Part 1 - Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01240278
- Acronym / sponsor ID
- 10-004506
- Conditions
- Dense Breasts, Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Nov 2010 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 15 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with mammographically dense breasts who demonstrate either photopenic or marked background parenchymal uptake on MBI.
Key inclusion criteria (7 listed)
- Age 40 or older
- Be postmenopausal as defined as having at least 12 consecutive months of amenorrhea
- Screening mammogram performed at Mayo Clinic Rochester within one year prior to the current MBI study which demonstrates
- MBI performed less than one month prior to biopsy demonstrating either significant FD or photopenic FD.
Key exclusion criteria (8 listed)
- 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.
- Personal history of any cancer, except non-melanomatous skin cancer
- Current breast symptoms
- Breast implants
- Known allergy to local anesthetic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
proportion of epithelium vs stroma
Time frame: within 1 month of functional density assessment on MBI
2 secondary outcomes
Degree of lobular involution
Time frame: within 1 month of functional density assessment on MBI
Ki-67 cellular proliferation index
Time frame: within 1 month of functional density assessment on MBI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Derived from this study: PubMed 41402965Bardwell Speltz L, Ghosh K, Visscher DW, Scott CG, Cole KC, Kroneman TN, Maxwell RW, Conners AL, Hunt KN, Rhodes DJ, Vachon CM, Hruska CB. Histologic correlates of background parenchymal uptake on molecular breast imaging. Breast Cancer Res. 2025 Dec 16;27(1):216. doi: 10.1186/s13058-025-02171-x.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carrie Hruska, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dense Breasts and Breast Cancer, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of epithelium vs stroma (time frame: within 1 month of functional density assessment on MBI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01240278, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.