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Positron Emission Tomography Before Surgery in Evaluating Women With Primary or Recurrent Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00039286
First received: June 6, 2002
Last updated: April 17, 2013
Last verified: April 2013
History of Changes
  Purpose

RATIONALE: Imaging procedures such as positron emission tomography (PET) may improve the ability to detect the extent of breast cancer.

PURPOSE: Diagnostic trial to study the effectiveness of PET to detect the extent of breast cancer in women who have primary or recurrent breast cancer.


Condition Intervention
Breast Cancer
 Procedure: positron emission tomography
Procedure: radionuclide imaging
Radiation: fludeoxyglucose F 18

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Pilot Study To Assess The Utility Of 18F-Fluorodeoxyglucose Positron Emission Tomography (PET) In The Pre-Operative Evaluation Of Patients With Primary And Recurrent Breast Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Determine the sensitivity, specificity, and accuracy [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 118
Study Start Date: October 2001
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Positron Emission Tomography
Patients receive fludeoxyglucose F 18 IV. Approximately 1 hour later, patients undergo positron emission tomography imaging. Some patients may undergo a repeat scan in 4-6 months.
 Procedure: positron emission tomography Procedure: radionuclide imaging Radiation: fludeoxyglucose F 18

Detailed Description:

OBJECTIVES:

  • Determine the sensitivity, specificity, and accuracy of fludeoxyglucose F 18 (FDG) positron emission tomography (PET) as compared to conventional imaging in determining the extent of disease in women with primary or recurrent breast cancer.
  • Determine how often clinical management and operative intervention plans for patients are altered based on these FDG-PET scan findings.
  • Determine whether FDG-PET results in more accurate detection of disease in these patients.

OUTLINE: Patients receive fludeoxyglucose F 18 IV. Approximately 1 hour later, patients undergo positron emission tomography imaging. Some patients may undergo a repeat scan in 4-6 months.

PROJECTED ACCRUAL: (50 with primary disease and 50 with recurrent disease) will be accrued for this study within 1-2 years.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of breast cancer for which surgical intervention is planned

    • Large primary breast cancer (i.e., larger than 5 cm, T3) as determined by prior biopsy, physical exam, or mammogram OR
    • Locally advanced breast cancer (T4) OR
    • Clinical suspicion of axillary nodal disease (N1-2) (i.e., stage IIB-IIIA) OR
    • Locally or regionally recurrent disease
  • No locally recurrent disease that is non-invasive (i.e., ductal carcinoma in situ)
  • No locally advanced disease (e.g., inflammatory breast cancer) that will be treated with neoadjuvant chemotherapy without surgery

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No other malignancy except previously treated nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No known active infection
  • No autoimmune disease or inflammatory disease (e.g., sarcoidosis or rheumatoid arthritis)
  • Able to fast for 6 hours and tolerate a FDG-PET scan for the duration of the test
  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039286

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Elisa Rush Port, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00039286     History of Changes
Other Study ID Numbers: 01-134, P30CA008748, MSKCC-01134, NCI-G02-2074
Study First Received: June 6, 2002
Last Updated: April 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
stage II breast cancer
stage IIIA breast cancer
recurrent breast cancer

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

ClinicalTrials.gov processed this record on May 23, 2013