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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 1

Conditions: Breast Cancer

Treatments: Procedure: positron emission tomography; Procedure: radionuclide imaging; Radiation: fludeoxyglucose F 18

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00039286

P30CA008748 (U.S. NIH Grant/Contract)

NCI-G02-2074

MSKCC-01134

01-134

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 patients

Sex: Female

Ages: Under 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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118 participants in 1 patient group

Positron Emission Tomography

Experimental group

Description:

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.

Treatment:

Procedure: positron emission tomography

Radiation: fludeoxyglucose F 18

Procedure: radionuclide imaging