N/A
N=969
Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00620373 ↗Enrolled (actual)
969
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Diagnostic Yield — 3.2; 9.6; 10.7 cancers per 1000 women screened — p=.016
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Molecular Breast Imaging (Device); Conventional Mammography (Device); Technetium (99mTc) sestamibi (Drug)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- Female
- Sponsor
- Mayo Clinic
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Yield |
3.2; 9.6; 10.7 | .016 sig |
| PRIMARY Number of Participants With Cancer Diagnosis at 12 Months |
7; 4 | — |
| SECONDARY Sensitivity |
3; 9; 10; 2; 7; 7 | .016 sig |
| SECONDARY Specificity |
840; 861; 788 | <.001 sig |
| SECONDARY Recall Rate |
9; 8; 15 | <.001 sig |
Summary
We aim to compare the sensitivity of mammography to the sensitivity of Molecular Breast Imaging (a new gamma-camera based breast imaging technology) in women with dense breast tissue who are at increased risk for breast cancer.
Eligibility Criteria
Inclusion Criteria
- Past prior screening mammography (SM) interpreted as negative or benign (This screening must have been performed at Mayo Clinic Rochester, Minnesota).
- Past prior SM interpreted as heterogeneously dense or extremely dense (This screening must have been performed at Mayo Clinic Rochester, Minnesota).
- Women younger than 50 years who had not undergone prior mammography, as most of these women have dense breasts.
- Subjects had to have at least one of the following risk factors:
- Known mutation in breast cancer susceptibility gene 1 (BRCA1) or breast cancer susceptibility gene 2 (BRCA2)
- History of chest, mediastinal, or axillary irradiation
- Personal history of breast cancer
- History of prior biopsy showing atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in situ, or atypical papilloma
- Gail or Claus model lifetime risk greater than or equal to 20%
- Gail model 5 year risk greater or equal to 2.5%
- Gail model 5 year risk greater or equal to 1.6%
- One first-degree relative with history of breast cancer
- Two second-degree relatives with history of breast cancer
Exclusion Criteria
- They are unable to understand and sign the consent form
- They are pregnant or lactating
- They are physically unable to sit upright and still for 40 minutes.
- They have self-reported signs or symptoms of breast cancer (palpable mass, bloody nipple discharge, axillary mass etc.).
- They have had needle biopsy within 3 months, or breast surgery within 1 year prior to the study.
- They are currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor for adjuvant therapy or chemoprevention.
Data sourced from ClinicalTrials.gov (NCT00620373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.