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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. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00688337
First Posted: June 2, 2008
Last Update Posted: June 2, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tel-Aviv Sourasky Medical Center
  Purpose
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.

Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Correlation between FDG and FLT uptake and hystological findings and Oncotype results [ Time Frame: One year after imaging ]

Secondary Outcome Measures:
  • Clinical outcome [ Time Frame: A year after imaging ]

Biospecimen Retention:   None Retained
not relevant

Estimated Enrollment: 100
Study Start Date: June 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with newly diagnosed breast cancer. Clinically nodal negative.

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

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Ages Eligible for Study:   18 Years to 86 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed patients with breast cancer, clinically nodal negative, prior to surgery and/or treatment
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688337


Contacts
Contact: Einat Even-Sapir, MD, PhD 972-3-697-3536 evensap@tasmc.health.gov.il

Locations
Israel
Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Einat Even-Sapir, MD, PhD    972-3-697-3536    evensap@tasmc.health.gov.il   
Contact: Limor Zuriel, MSc    972-3-697-3536    limorz@tasmc.health.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
  More Information

Responsible Party: Einat Even-Sapir MD, PhD, Dept of Nuclear Medicine, Tel Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00688337     History of Changes
Other Study ID Numbers: TASMC-08-EE-108-CTIL
First Submitted: May 28, 2008
First Posted: June 2, 2008
Last Update Posted: June 2, 2008
Last Verified: May 2008

Keywords provided by Tel-Aviv Sourasky Medical Center:
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases