Project Details
Description
PROJECT SUMMARY/ABSTRACT
While great strides have been made in reducing breast cancer mortality over the last two decades, most of this
reduction is attributed to advances in treatment. Screening’s contribution to breast cancer mortality reduction has
been stagnant as screening continues to rely on mammography’s x-ray technology that preferentially detects less
aggressive cancers and can mask tumors in dense breasts, due to the similar x-ray attenuation characteristics of
breast tumors and dense tissue. Over half of women who undergo screening in the US have mammographically
dense breasts (MDB), and mammography fails to detect 75% of cancers in women with MDB when it is compared
to a functional screening tool such as MRI. However, the cost and complexity of MRI as well as concerns about
safety and tolerability have been barriers to screening women with MDB, and there remains no consensus on
whether or how supplemental screening should be performed in women with MDB, which underscores the need for
a functional modality with a more favorable cost, tolerability, and safety profile.
Molecular Breast Imaging (MBI) is a functional screening tool that utilizes gamma detectors to image the
preferential uptake of a radiotracer in breast cancers. Like MRI, MBI detects invasive breast cancers that are not
visible on mammography due to breast density and preferentially detects aggressive cancers, but is less costly and
complex to interpret compared to MRI. MBI has shown promise when evaluated in single-center studies, but has
yet to be evaluated across diverse breast imaging practices and patient populations, and has yet to be compared to
3D mammography (also known as digital breast tomosynthesis [DBT]), which is becoming the new standard
screening mammography test. This need for multicenter validation, coupled with additional concerns about cost and
radiation dose have limited MBI adoption to date.
We propose the Density MATTERS (Molecular Breast Imaging and Tomosynthesis to Eliminate the Reservoir of
Undetected Cancers) clinical trial in which 3000 women will undergo concurrent MBI and DBT at study entry and
one year later. We hypothesize that MBI, whether in combination with DBT or alone, will detect at least twice as
many invasive cancers as DBT and will lead to fewer advanced cancers in the second year of screening, which are
associated with higher breast cancer mortality. We will also compare the costs of these two screening approaches
and validate a new image processing tool so MBI can be acquired at a radiation effective dose as low as DBT.
This project is timely as a February 2019 federal law now mandates that women with MDB are informed of the risk
of tumor masking on mammography. Thus, up to half of women nationwide will be seeking a solution for improved
screening. Project outcomes could change clinical practice for women with MDB by validating MBI as an
immediately available, safe and well-tolerated screening solution to detect invasive cancers missed on
mammography and DBT, without increasing costs or radiation exposure.
Status | Active |
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Effective start/end date | 9/1/20 → 5/31/24 |
Funding
- National Cancer Institute: $646,649.00
- National Cancer Institute: $646,651.00
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