Feasibility Study Using Imaging Biomarkers in Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02095808|
Recruitment Status : Recruiting
First Posted : March 26, 2014
Last Update Posted : January 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Procedure: Imaging Biomarkers||Not Applicable|
The recent report of the findings of the National Lung Screening Trial indicates that screening a high-risk population using low dose CT results in a 20% reduction in lung cancer mortality. At our institution, some of positive nodules that are 1 cm or larger would be imaged using combined fluoro-deoxyglucose positron emission tomography (FDG PET)/CT. Highly suspicious nodules would be biopsied if the risks were manageable. Otherwise, the suspicious nodules not eligible for biopsy and so-called "indeterminate" nodules are followed using CT to be evaluated for interval growth.
The overall goal of this project is to assess several very promising imaging biomarkers that can reflect either the physiological or metabolic status of these nodules in order to develop more accurate imaging algorithms for follow-up that are either less invasive or do not use ionizing radiation or both. Based on our experience with other cancers and our preliminary results in lung cancer, we have identified four potential imaging studies that we believe have the potential to result in validated "imaging biomarkers" that can either individually, or in combination, characterize malignancies. Since tumors tend to exhibit angiogenesis and altered vascular permeability, we and others, have found that analyses of dynamic contrast enhanced MRI (DCEMRI) can be employed as "imaging biomarkers" for malignancy. Tumors often exhibit higher cellularity than benign or normal tissue suggesting that pixel-by-pixel ADC values derived from diffusion weighted MRI could be useful imaging biomarkers. Finally, measuring alterations in metabolic fluxes through the use of pathway specific C-13 labeled compounds, a technique pioneered here at the Advanced Imaging Research Center (AIRC) at UT Southwestern, has shown the capability of providing metabolic fingerprints for malignant and benign tissue. This approach, while invasive, could identify and validate markers that can be detected non-invasively in future studies. We will also employ advanced metabolomics methods to identify potential signature "onco-metabolites" in these lung cancers.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||153 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Feasibility Study Using Imaging Biomarkers in Lung Cancer|
|Actual Study Start Date :||March 20, 2013|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
The 13C-glucose solution will be given intravenously. It will be started at about the same time as the start of surgery, according to the study guidelines.
The 13C-glucose IV solution will be stopped once the surgeon has removed the tumor tissue.
Procedure: Imaging Biomarkers
Want to see if using 13C-glucose helps in detecting cancer and deciding on a treatment plan.
- DCE-MRI [ Time Frame: One time - within 5 days of the scheduled surgery ]Physicians and researchers will review the results of the imaging to determine if the patient will receive the [U-13C] glucose infusion.
- C-13 isotopomer [ Time Frame: During the infusion period blood samples will be collected every 30 minutes (for 2-3 hours) until the end of tumor sampling for mass spec and NMR analyisis of C-glucose in the blood. ]Employ C-13 isotopomer analysis and metabolomics on specimens obtained from resected tissue of suitable patients in this cohort to determine the metabolic alterations present in lung cancer.
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): NCT02095808
|Contact: Jessica Saltarski||214-648-7023||Jessica.Saltarski@UTSouthwestern.edu|
|United States, Texas|
|University of Texas Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Jessica Saltarski 214-648-7023 Jessica.Saltarski@utsouthwestern.edu|
|Principal Investigator:||Kemp H Kernstine, MD||University of Texas Southwestern Medical Center|