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Trial Comparing the Use of Fluoro-L-thymidine Positron Emission Tomography (FLT PET) to Standard Computed Tomography to Assess Treatment Response of Neoadjuvant Docetaxel and Cisplatin in Stage IB-IIIA Resectable Non-Small Lung Cancer

2014-08-27 03:19:51 | BioPortfolio

Summary

The purposes of this study are:

- To determine if the absolute decrease measured in primary tumor fluoro-L-thymidine (FLT) uptake maximum standardized uptake value and kinase (SUV max and Ki) between pre-treatment imaging and imaging after the first cycle of therapy differs in patients categorized as responders or non-responders based on classic clinical tumor radiographic response status (RECIST) measured after the second cycle of therapy.

- To determine if the absolute decrease measured in primary tumor FDG uptake (SUV lean-max) between pre-treatment imaging and imaging after the first cycle of therapy differs in patients categorized as responders or non-responders based on classic clinical tumor radiographic response status (RECIST) measured after the second cycle of therapy.

- To assess the effects of the combination of docetaxel and cisplatin on fractional tumor viability and proliferative fraction pre and post treatment and to correlate these with the PET SUV data for both tracers.

- To assess the methylation status of the dihydrofolate reductase gene gene from pre-treatment tumor biopsies and correlate methylation status with clinical and pathologic response.

Study Design

Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Non Small Cell Lung Cancer

Intervention

FLT PET, Neoadjuvant Docetaxel and Cisplatin

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore
Maryland
United States
21231

Status

Recruiting

Source

Sidney Kimmel Comprehensive Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:51-0400

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