drugset / Trial / NCT01925170

Low Dose Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts

NCT01925170

NaSingle-groupSingle-blindDiagnostic

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.

Timeline

Start
2009-04
Primary completion
2013-06
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Background TECHNETIUM SESTAMIBI Diagnostic / imaging agent 740 mbq Other

Indications