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

This study has been completed.
Sponsor:
Collaborator:
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

June 6, 2002
April 17, 2013
October 2001
February 2009   (final data collection date for primary outcome measure)
Determine the sensitivity, specificity, and accuracy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00039286 on ClinicalTrials.gov Archive Site
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Positron Emission Tomography Before Surgery in Evaluating Women With Primary or Recurrent Breast Cancer
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

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
  • Procedure: positron emission tomography
  • Procedure: radionuclide imaging
  • Radiation: fludeoxyglucose F 18
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.
Interventions:
  • Procedure: positron emission tomography
  • Procedure: radionuclide imaging
  • Radiation: fludeoxyglucose F 18
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
118
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00039286
01-134, P30CA008748, MSKCC-01134, NCI-G02-2074
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Elisa Rush Port, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP