- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00688337
Correlation Between Fluorodeoxyglucose (FDG) and FLT Uptake and Gene-Expression Oncotype Assay in Patients With Breast Cancer
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Tel Aviv, Israel, 64239
- Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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1
Patients with newly diagnosed breast cancer.
Clinically nodal negative.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Correlation between FDG and FLT uptake and hystological findings and Oncotype results
Tidsram: One year after imaging
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One year after imaging
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Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Clinical outcome
Tidsram: A year after imaging
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A year after imaging
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- TASMC-08-EE-108-CTIL
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