Correlation Between Fluorodeoxyglucose (FDG) and FLT Uptake and Gene-Expression Oncotype Assay in Patients With Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: 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
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Not yet recruiting
Summary
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 86 Years
Minimum Age: 18 Years
Gender: Female
Criteria: 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
Location
Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Status: Recruiting
Contact: Einat Even-Sapir, MD, PhD - 972-3-697-3536 - evensap@tasmc.health.gov.il
Start Date
June 2008
Completion Date
June 2010
Sponsors
Tel-Aviv Sourasky Medical Center
Source
Tel-Aviv Sourasky Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page