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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Chair: Elisa Rush Port, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
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
Fluorodeoxyglucose F18
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014