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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00688337

Enrollment

100

Registered

2008-06-02

Start date

2008-06-30

Completion date

2010-06-30

Last updated

2008-06-02

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

Conditions

Breast Cancer

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

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 86 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Clinical outcome	A year after imaging

Countries

Israel

Contacts

Primary ContactEinat Even-Sapir, MD, PhD

evensap@tasmc.health.gov.il972-3-697-3536

Outcome results