Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts
|ClinicalTrials.gov Identifier: NCT00620373|
Recruitment Status : Completed
First Posted : February 21, 2008
Results First Posted : December 30, 2013
Last Update Posted : August 1, 2014
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: Molecular Breast Imaging Device: Conventional Mammography Drug: Technetium (99mTc) sestamibi||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||969 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
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
- Diagnostic Yield [ Time Frame: 12 months after mammography and gamma imaging ]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 ]
- Sensitivity [ Time Frame: 12 months after mammography and gamma imaging ]Sensitivity measures the proportion of actual positives which are correctly identified as such.
- Specificity [ Time Frame: 12 month after mammography and gamma imaging ]Specificity measures the proportion of negatives which are correctly identified as such.
- Recall Rate [ Time Frame: 12 months after mammography and gamma imaging ]Recall rate was defined as the percentage of participants recalled for follow-up studies initiated because of abnormal findings with mammography or gamma imaging.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00620373
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Deborah J. Rhodes, M.D.||Mayo Clinic|