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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00039286

Enrollment

118

Registered

2003-01-27

Start date

2001-10-31

Completion date

2009-02-28

Last updated

2015-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage II breast cancer, stage IIIA breast cancer, recurrent breast cancer

Brief summary

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.

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.

Interventions

PROCEDUREpositron emission tomography

PROCEDUREradionuclide imaging

RADIATIONfludeoxyglucose F 18

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

No minimum to 120 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Determine the sensitivity, specificity, and accuracy	2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026