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Evaluation of Multimodality Breast Imaging: Project 3-Lesion Staging


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

Evaluation of Multimodality Breast Imaging: Project 3-Lesion Staging


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Size of the index lesion (3 dimensions and tumor volume)

Safety Issue:

No

Principal Investigator

Abass Alavi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Federal Government

Study ID:

CDR0000515329

NCT ID:

NCT00194337

Start Date:

October 1999

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • Breast Neoplasms

Name

Location
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283