Positron Emission Tomography Before Surgery in Evaluating Women With Primary or Recurrent Breast Cancer - Full Text View

Sponsor:	Memorial Sloan-Kettering Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00039286

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:	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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Nuclear Scans

Drug Information available for: Fluorodeoxyglucose F18

U.S. FDA Resources

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

Estimated Enrollment:	100
Study Start Date:	October 2001
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

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: A total of 100 patients (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

Study ID Numbers:	CDR0000069369, MSKCC-01134, NCI-G02-2074
Study First Received:	June 6, 2002
Last Updated:	March 7, 2009
ClinicalTrials.gov Identifier:	NCT00039286 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage II breast cancer
stage IIIA breast cancer
recurrent breast cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009