Digital Mammography, Ultrasound, MRI, & PET Scans in Women With Newly

Status Unknown status

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00194337
Study type	Interventional
Source	Abramson Cancer Center of the University of Pennsylvania
Contact
Status	Unknown status
Phase	Phase 2/Phase 3
Start date	October 1999

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Digital Mammography, Ultrasound, MRI, and PET Scans in Women With Newly Diagnosed Breast Cancer

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms