Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts
Device: Molecular Breast Imaging
Device: Conventional Mammography
Drug: Technetium (99mTc) sestamibi
|Study Design:||Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
|Official Title:||Evaluation of Low-dose Molecular Breast Imaging as a Screening Tool in Women With Mammographically Dense Breasts and Increased Risk of Breast Cancer|
- Diagnostic Yield [ Time Frame: 12 months after mammography and gamma imaging ] [ Designated as safety issue: No ]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).
- Number of Participants With Cancer Diagnosis at 12 Months [ Time Frame: 12 months after mammography and gamma imaging ] [ Designated as safety issue: No ]
- Sensitivity [ Time Frame: 12 months after mammography and gamma imaging ] [ Designated as safety issue: No ]Sensitivity measures the proportion of actual positives which are correctly identified as such.
- Specificity [ Time Frame: 12 month after mammography and gamma imaging ] [ Designated as safety issue: No ]Specificity measures the proportion of negatives which are correctly identified as such.
- Recall Rate [ Time Frame: 12 months after mammography and gamma imaging ] [ Designated as safety issue: No ]Recall rate was defined as the percentage of participants recalled for follow-up studies initiated because of abnormal findings with mammography or gamma imaging.
|Study Start Date:||August 2005|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Experimental: Mammography and Molecular Breast Imaging
Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (20-mCi) Technetium (99mTc) sestamibi injection.
Device: Molecular Breast Imaging
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.Device: Conventional Mammography
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.Drug: Technetium (99mTc) sestamibi
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.
Other Name: Cardiolite
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00620373
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Deborah J. Rhodes, M.D.||Mayo Clinic|