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.
The sensitivity of conventional mammography (MMO) is poor in women with mammographically dense breast parenchyma. We have developed Molecular Breast Imaging (MBI) - a new technique which utilizes a Cadmium-Zinc-Telluride (CZT) gamma camera for scintimammography that has a high sensitivity (\~90%) for the detection of breast cancers independent of breast density. The aim of this study is to demonstrate the utility of MBI as an adjunct screening modality for the detection of occult breast cancers in women with mammographically dense breast tissue. Initial recruitment will be from the pool of patients awaiting a screening mammogram in the Department of Radiology at Mayo Clinic Rochester. All patients will have a screening MMO and an MBI study. Patients with positive studies (MBI or MMO) will undergo additional diagnostic studies. At 15 months post-recruitment, all patients will be contacted by phone or mail to determine whether subsequent to their study, there has been any change in their breast status.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
969
Molecular breast imaging is a new nuclear medicine technique for imaging the breast. It uses small field of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.
Mammography is the process of using low-energy X-rays (usually around 30 kVp) to examine the human breast and is used as a diagnostic and a screening tool.
Technetium (99mTc) sestamibi is a pharmaceutical agent used in nuclear medicine imaging. The drug is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands.
Mayo Clinic
Rochester, Minnesota, United States
Diagnostic Yield
Diagnostic yield is the likelihood that a test or procedure will provide the information needed to establish a diagnosis. In this case, it is the proportion of women with positive results of a screening test and positive results with the reference standard (verified cancer status).
Time frame: 12 months after mammography and gamma imaging
Number of Participants With Cancer Diagnosis at 12 Months
Time frame: 12 months after mammography and gamma imaging
Sensitivity
Sensitivity measures the proportion of actual positives which are correctly identified as such.
Time frame: 12 months after mammography and gamma imaging
Specificity
Specificity measures the proportion of negatives which are correctly identified as such.
Time frame: 12 month after mammography and gamma imaging
Recall Rate
Recall rate was defined as the percentage of participants recalled for follow-up studies initiated because of abnormal findings with mammography or gamma imaging.
Time frame: 12 months after mammography and gamma imaging
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.