Correlation Between Fluorodeoxyglucose (FDG) and FLT Uptake and Gene-Expression Oncotype Assay in Patients With Breast Cancer

In the current study FDG (Fluorodeoxyglucose) uptake, FLT uptake (F18-Fluoro-3'-deoxythymidine) and their ratios will be correlated with the risk score results of the Oncotype gene-expression assay in patients with clinically negative nodal disease planned for surgical removal of the tumor.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer

Detailed Description

Several publications have addressed the role of PET imaging for biological characterization of breast cancer. A modest but significant correlation was reported between tumor grading and FDG uptake. Few studies reported a positive correlation between SUV and the Ki-67 labeling index of malignant breast tumors. Others have correlated p53 expression in breast cancer and FDG uptake. F18-Fluoro-3'-deoxythymidine (FLT) has been developed as a PET marker for cellular proliferation has been developed for imaging cell proliferation and findings correlate strongly with the Ki-67 labeling index in breast cancer. A 10-minute FLT-PET scan acquired two weeks after the end of the first course of chemotherapy, has been shown in two recent studies to be useful for predicting longer-term efficacy of chemotherapy regimens for women with breast cancer.

In the current study FDG and FLT uptake and their ratios will be correlated with the risk score results of the Oncotype gene-expression assay in patients with clinically negative nodal disease planned for surgical removal of the tumor. It is our hypothesis that since high uptake of these tracers implies aggressive behavior and rapid tumor growth, it might well be that patients with high risk score on Oncotype will have high uptake of the PET tracers and those with low risk score will show low-intensity uptake values. If this will be the case, it might well be that in patients with non-conclusive oncotype results (intermediate score) FDG and FLT uptake measurement will allow further dichotomy to 1. Patients with intermediate score on Oncotype and high uptake of the PET tracers, suggestive of aggressive behavior and 2. Patients with intermediate score on Oncotype and low uptake of the PET tracers suggesting a less aggressive behavior.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 64239
    • Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed patients with breast cancer, clinically nodal negative, prior to surgery and/or treatment

Description

Inclusion Criteria:

• Newly diagnosed patients with breast cancer
• clinically nodal negative
• prior to surgery and/or treatment
• age over 18 years

Exclusion Criteria:

• Age under 18
• Pregnancy
• Previous therapy for breast cancer
• Clinical or histological evidence of nodal involvement or other proven metastatic sites

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; Patients with newly diagnosed breast cancer. Clinically nodal negative.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation between FDG and FLT uptake and hystological findings and Oncotype results	One year after imaging

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical outcome	A year after imaging

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Anticipated): June 1, 2009
• Study Completion (Anticipated): June 1, 2010

Study Registration Dates

• First Submitted: May 28, 2008
• First Submitted That Met QC Criteria: May 30, 2008
• First Posted (Estimate): June 2, 2008

Study Record Updates

• Last Update Posted (Estimate): June 2, 2008
• Last Update Submitted That Met QC Criteria: May 30, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: Breast cancer; lymph nodes; gene-expression; oncotype; Age over 18; Newly diagnosed breast cancer prior to surgery or treatment.; No evidence of clinical nodal disease
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: TASMC-08-EE-108-CTIL