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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


N/A
N/A
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Determine the sensitivity, specificity, and accuracy

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Elisa Rush Port, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

01-134

NCT ID:

NCT00039286

Start Date:

October 2001

Completion Date:

February 2009

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021