Tomosynthesis in Screening Mammography
Summary
Tomosynthesis is a new digital mammographic tool which can be performed at the same time as routine screening mammography. It creates CT-like slices through the breast, minimizing the tissue overlap. Tomosynthesis has the potential to improve screening mammography outcomes by increasing cancer detection rate, decreasing false negative rates and false positive rates. This trial will help determine if tomosynthesis is useful in a screening setting.
Description
We will evaluate the effect of tomosynthesis mammography outcomes in a screening setting. We will collect data on interpretation time, recall rates, cancer detection rates, and interval cancer rates in dense breasts(≥ 50% glandular density). If the interpretation time is less than 4X a routine read, and the recall rates have dropped < 30% of initial values, we will then conduct a study with larger numbers to better evaluate cancer detection rates and interval cancer rates.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Conditions
Breast Density ≥ 50%
Intervention
tomosynthesis
Location
Alberta Screen Test
Edmonton
Alberta
Canada
Status
Not yet recruiting
Source
Alberta Health Services
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01086241
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Breast Cyst
A fluid-filled closed cavity or sac that is lined by an EPITHELIUM and found in the BREAST. It may appear as a single large cyst in one breast, multifocal, or bilateral in FIBROCYSTIC BREAST DISEASE.
Fibrocystic Breast Disease
A common and benign breast disease characterized by varying degree of fibrocystic changes in the breast tissue. There are three major patterns of morphological changes, including FIBROSIS, formation of CYSTS, and proliferation of glandular tissue (adenosis). The fibrocystic breast has a dense irregular, lumpy, bumpy consistency.
Inflammatory Breast Neoplasms
Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.
Mucin-1
Carbohydrate antigen elevated in patients with tumors of the breast, ovary, lung, and prostate as well as other disorders. The mucin is expressed normally by most glandular epithelia but shows particularly increased expression in the breast at lactation and in malignancy. It is thus an established serum marker for breast cancer.
Centrifugation, Density Gradient
Separation of particles according to density by employing a gradient of varying densities. At equilibrium each particle settles in the gradient at a point equal to its density. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)
Clinical Trials
The main objective of the study is to assess the sensitivity and specificity of Tomosynthesis in detecting the multicentricity of mammary tumor.
Digital Breast Tomosynthesis Preference Study
Mammography remains the current standard in the detection of breast cancer. However, conventional two-view mammography will not detect all cancers. The major limiting factor of conventio...
Malmö Breast Tomosynthesis Screening Trial
To compare digital breast tomosynthesis (DBT) with full field digital mammography (FFDM) regarding effectiveness as screening modalities.
Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment
The objective of this study is to demonstrate that digital breast tomosynthesis (DBT) in combination with full field digital mammography (FFDM) has the potential to reduce significantly ba...
The purpose of this study is to compare 3D mammography with digital mammography in women with dense breasts for the detection and evaluation of masses and/or breast cancer.
PubMed Articles
OBJECTIVE: To compare breast density on digital mammography and digital breast tomosynthesis using fully automated software. METHODS: Following institutional approval and written informed consent from...
OBJECTIVES: To compare the diagnostic performance of single-view breast tomosynthesis (BT) with that of dual-view mammography (MX); to assess the benefit of adding the craniocaudal (CC) mammographic v...
One-to-one comparison between digital spot compression view and digital breast tomosynthesis.
OBJECTIVE: To assess if digital breast tomosynthesis (DBT) is at least equal to digital spot compression view (DSCV). METHODS:...
A formalism is proposed for the estimation of mean glandular dose for breast tomosynthesis, which is a simple extension of the UK, European and IAEA protocols for dosimetry in conventional projection...
OBJECTIVES: To compare the diagnostic performance of tomosynthesis with that of chest radiography for the detection of pulmonary emphysema, using multidetector computed tomography (MDCT) as reference....
