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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00688337
First received: May 28, 2008
Last updated: May 30, 2008
Last verified: May 2008

May 28, 2008
May 30, 2008
June 2008
June 2009   (final data collection date for primary outcome measure)
Correlation between FDG and FLT uptake and hystological findings and Oncotype results [ Time Frame: One year after imaging ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00688337 on ClinicalTrials.gov Archive Site
Clinical outcome [ Time Frame: A year after imaging ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Correlation Between Fluorodeoxyglucose (FDG) and FLT Uptake and Gene-Expression Oncotype Assay in Patients With Breast Cancer
Not Provided

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:

not relevant

Non-Probability Sample

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

Breast Cancer
Not Provided
1
Patients with newly diagnosed breast cancer. Clinically nodal negative.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
June 2010
June 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 86 Years
No
Contact: Einat Even-Sapir, MD, PhD 972-3-697-3536 evensap@tasmc.health.gov.il
Israel
 
NCT00688337
TASMC-08-EE-108-CTIL
Yes
Einat Even-Sapir MD, PhD, Dept of Nuclear Medicine, Tel Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
Not Provided
Not Provided
Tel-Aviv Sourasky Medical Center
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP