Digital Mammography, Ultrasound, MRI, and PET Scans in Women With Newly Diagnosed Breast Cancer
RATIONALE: Diagnostic procedures, such as digital mammography, ultrasound, MRI, and PET scans, may help find breast cancer and find out how far the disease has spread.
PURPOSE: This phase II/III trial is studying digital mammography, ultrasound, MRI, and PET scans to compare how well they find the extent and spread of breast cancer in women with newly diagnosed breast cancer.
Procedure: breast imaging study
Procedure: comparison of screening methods
Procedure: magnetic resonance imaging
Procedure: positron emission tomography
Procedure: ultrasound imaging
Radiation: fludeoxyglucose F 18
|Study Design:||Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Evaluation of Multimodality Breast Imaging: Project 3-Lesion Staging|
- Size of the index lesion (3 dimensions and tumor volume) [ Designated as safety issue: No ]
- Relative sensitivity/specificity of imaging in identifying additional cancer foci at least 2 cm from the index lesion margin [ Designated as safety issue: No ]
- Relative yield of imaging in detecting lymph node and distant metastases [ Designated as safety issue: No ]
- Positive predictive value of imaging-identified suspicious incidental lesions [ Designated as safety issue: No ]
- Negative predictive value of imaging (compared to mastectomy sectioning) for identifying unifocal disease [ Designated as safety issue: No ]
- Imaging features predictive of lymph node status [ Designated as safety issue: No ]
|Study Start Date:||October 1999|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
- Compare the ability of digital mammography, ultrasound, MRI, and fludeoxyglucose F 18 positron emission tomography (FDG-PET) in depicting the extent of the index lesion within an affected breast in women with newly diagnosed breast cancer.
- Compare the ability of digital mammography, ultrasound, MRI, and FDG-PET in identifying additional foci of cancer in the affected breast.
- Estimate the accuracy of FDG-PET in predicting the status of the axillary lymph nodes, using sentinel node sampling as the gold standard.
- Determine whether diffuse or multifocal cancers detected on MRI, ultrasound, digital mammography, and FDG-PET can be predicted based on mammographic, clinical, or pathologic findings.
- Based on correlation of various imaging techniques and clinical and pathological findings, generate a profile of patients at risk for mammographically and clinically occult, diffuse or multifocal disease.
- Collect pilot data on the accuracy of digital tomosynthesis in determining the extent of breast cancer (in women consenting to the contrast-enhanced tomosynthesis study).
OUTLINE: This is a prospective study. Patients are stratified according to breast density (fatty vs scattered/less than 50% dense vs heterogeneously dense/greater than 50% dense vs extremely dense), presentation (palpable abnormalities vs imaging abnormalities only), and image findings (density vs calcification).
Patients undergo MRI, ultrasound, digital mammography, and fludeoxyglucose F 18 positron emission tomography. Results of imaging are compared by a panel of physicians to determine efficacy of each method. Consenting patients also undergo digital tomosynthesis with or without contrast enhancement.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00194337
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Abass Alavi, MD||Abramson Cancer Center of the University of Pennsylvania|