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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00039286
• Other study ID #: 01-134
• Secondary ID: P30CA008748MSKCC
• Status: Completed
• Phase: Phase 1
• First received: June 6, 2002
• Last updated: December 23, 2015
• Start date: October 2001
• Est. completion date: February 2009

Study information

• Verified date: December 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 120 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• positron emission tomography

• radionuclide imaging

Radiation:
• fludeoxyglucose F 18

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the sensitivity, specificity, and accuracy		2 years	No