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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00194337
First received: September 13, 2005
Last updated: May 9, 2009
Last verified: January 2007
  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.


Condition Intervention Phase
Breast Cancer
Procedure: breast imaging study
Procedure: comparison of screening methods
Procedure: magnetic resonance imaging
Procedure: positron emission tomography
Procedure: radiomammography
Procedure: ultrasound imaging
Radiation: fludeoxyglucose F 18
Phase 2
Phase 3

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Multimodality Breast Imaging: Project 3-Lesion Staging

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 400
Study Start Date: October 1999
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00194337

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Abass Alavi, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00194337     History of Changes
Other Study ID Numbers: CDR0000515329, UPCC-12199, UPCC-414500
Study First Received: September 13, 2005
Last Updated: May 9, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014