N/A
N=1,638
Low Dose Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01925170 ↗Enrolled (actual)
1,638
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Cancer Detection Rate Per 1000 Women Screened, by Breast Density — 3.2; 12.0; 10.7; 0 cancers per 1000 women screened — p=<0.001
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 · 40+ yrs
- Sex
- Female
- Sponsor
- Mayo Clinic
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cancer Detection Rate Per 1000 Women Screened, by Breast Density |
3.2; 12.0; 10.7; 0; 21.0; 21.0 | <0.001 sig |
| SECONDARY Specificity |
89.1; 83.4; 93.5 | <0.001 sig |
| SECONDARY Sensitivity for All Cancers Diagnosed |
23.8; 90.5; 81.0 | < 0.001 sig |
| SECONDARY Recall Rate |
11.0; 17.6; 7.5 | < 0.001 sig |
| SECONDARY Biopsy Rate |
1.3; 4.2; 3.2 | <0.001 sig |
Summary
A new test for breast cancer screening, molecular breast imaging (MBI) may be more sensitive than mammography for detecting breast cancer in women with dense breasts. The purpose of this study is to see if MBI using a low dose of gamma radiation can find cancers not seen on mammography.
Hypotheses: 1. Low-Dose MBI has a significantly higher sensitivity and specificity and equal or higher positive predictive value than SM in women age 40 and older with mammographically dense breasts. 2. Low-dose MBI has comparable sensitivity and specificity to that previously achieved with MBI using a higher dose of radiation. 3. MBI produces a low false positive rate (specificity >90%) that permits its use as a screening tool in this patient population.
Eligibility Criteria
Inclusion Criteria
- Past prior SM interpreted as negative or benign [Breast Imaging Reporting and Data System (BI-RADS) Category 1 or 2]
- Past prior SM interpreted as heterogeneously dense or extremely dense
Exclusion Criteria
- Subject is unable to understand and sign the consent form
- Subject is pregnant or lactating
- Subject is physically unable to sit upright and still for 40 minutes
- Subject has self-reported signs or symptoms of breast cancer (palpable mass, bloody nipple discharge, axillary mass, etc.)
- Subject has had needle biopsy within 3 months, or breast surgery within 1 year prior to the study
- Subject is currently taking tamoxifen, Evista (raloxifene), Zoladex or an aromatase inhibitor for adjuvant therapy or chemoprevention.
Data sourced from ClinicalTrials.gov (NCT01925170). 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.