Expired Study
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Philadelphia, Pennsylvania 19104


Purpose:

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.


Study summary:

OBJECTIVES: - 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.


Criteria:

DISEASE CHARACTERISTICS: - Confirmed diagnosis of breast cancer by biopsy - Malignant fine-needle aspiration, core needle, mammotome, or excisional biopsy - Newly diagnosed disease - Has undergone a film screening mammogram within the past 90 days - Planning to undergo definitive surgery at the Hospital of the University of Pennsylvania - No cancer in the ipsilateral breast within the past 5 years - Hormone receptor status not specified PATIENT CHARACTERISTICS: - Female - Menopausal status not specified - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Blood glucose ≤ 200 mg/dL - No contraindications to MRI including, but not limited to, any of the following: - Pacemaker - Magnetic aneurysm clip or other surgically implanted magnetic device - Severe claustrophobia - No prior allergic reaction to iodinated contrast agents or a history of severe allergic reactions to other drugs or foods (for patients consenting to the contrast-enhanced tomosynthesis study) PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No preoperative adjuvant therapy for known locally advanced cancer - Concurrent participation in other breast cancer studies allowed for conditions in the contralateral breast - Participation in a prevention study for a high-risk population (for patients with negative or benign findings in the contralateral breast) allowed - Participation in another diagnostic study (for patients with abnormal imaging findings of the contralateral breast and are recommended for biopsy) allowed


NCT ID:

NCT00194337


Primary Contact:

Principal Investigator
Abass Alavi, MD
Abramson Cancer Center of the University of Pennsylvania


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19104
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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