Breast Cancer Clinical Trial
Official title:
Pilot Study to Examine Histological Characteristics of Mammographic Density With Molecular Breast Imaging: Part 1 - Postmenopausal Women
NCT number | NCT01240278 |
Other study ID # | 10-004506 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2010 |
Est. completion date | April 27, 2022 |
Verified date | July 2022 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | April 27, 2022 |
Est. primary completion date | April 27, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 40 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | proportion of epithelium vs stroma | within 1 month of functional density assessment on MBI | ||
Secondary | 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. | within 1 month of functional density assessment on MBI | |
Secondary | 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. | within 1 month of functional density assessment on MBI |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Recruiting |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |