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

Breast Cancer Clinical Trial

Official title:

Evaluation of Multimodality Breast Imaging: Project 3-Lesion Staging

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00194337
• Other study ID #: CDR0000515329
• Secondary ID: UPCC-12199UPCC-4
• Status: Unknown status
• Phase: Phase 2/Phase 3
• Start date: October 1999

Study information

• Verified date: January 2007
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 400
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• breast imaging study

• comparison of screening methods

• magnetic resonance imaging

• positron emission tomography

• radiomammography

• ultrasound imaging

Radiation:
• fludeoxyglucose F 18

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Size of the index lesion (3 dimensions and tumor volume)
Primary	Relative sensitivity/specificity of imaging in identifying additional cancer foci at least 2 cm from the index lesion margin
Primary	Relative yield of imaging in detecting lymph node and distant metastases
Secondary	Positive predictive value of imaging-identified suspicious incidental lesions
Secondary	Negative predictive value of imaging (compared to mastectomy sectioning) for identifying unifocal disease
Secondary	Imaging features predictive of lymph node status