Clinical trial NCT00688337: Correlation Between Fluorodeoxyglucose (FDG) and FLT Uptake and Gene-Expression Oncotype Assay in Patients With Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-06-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed patients with breast cancer, clinically nodal negative, prior to surgery and/or treatment

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.

Eligibility 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

Primary outcomes:
measure: Correlation between FDG and FLT uptake and hystological findings and Oncotype results
timeFrame: One year after imaging
Secondary outcomes:
measure: Clinical outcome
timeFrame: A year after imaging
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center
Study officials:
References: