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

NCT ID: NCT00688337

Last Updated: 2008-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-06-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Keywords

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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 Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients with newly diagnosed breast cancer. Clinically nodal negative.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

86 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dept of Nuclear Medicine, Tel Aviv Sourasky Medical Center

Locations

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Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Central Contacts

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Einat Even-Sapir, MD, PhD

Role: CONTACT

Phone: 972-3-697-3536

Email: [email protected]

Facility Contacts

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Einat Even-Sapir, MD, PhD

Role: primary

Limor Zuriel, MSc

Role: backup

Other Identifiers

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TASMC-08-EE-108-CTIL

Identifier Type: -

Identifier Source: org_study_id