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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 10, 2023
Sponsor:
Information provided by (Responsible Party):
Kemp Kernstine, University of Texas Southwestern Medical Center

Study Description
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Brief Summary:
The purpose of this research study is to develop a method of using magnetic resonance imaging (MRI) to evaluate solitary pulmonary nodules (mass in the lung smaller than 3 centimeters). A pulmonary nodule is a mass or growth on the lung. An MRI is a scanning device that uses magnets to make images (pictures) of the body. This study is being done to determine what series of reactions (metabolic pathways) pulmonary nodules use as they burn sugar as fuel for growth. The manner in which the tumor burns (metabolizes) sugar for fuel is being investigated by using a natural, slightly modified, sugar solution (13C-glucose) and studying a small sample of the tumor once it is removed at the time of surgery.

Condition or disease Intervention/treatment Phase
Lung Cancer Procedure: Imaging Biomarkers Not Applicable

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: N/A
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 2024
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Surgery

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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects of all races and ethnic origins over 18 years of age will be recruited.
  • Patients must have suspicious or known to be malignant solitary pulmonary nodule,5cm or less in size.

Exclusion Criteria:

  • Patients with a contraindication to MRI examinations will be excluded from this study.

Contraindications to MRI examinations include:

  • Medically unstable

    • Heart failure
    • Unstable angina
    • Child bearing
    • Lactating
  • Not a surgical candidate

  • Any contraindication per MRI Screening Form (Appendix A attached). This is the same form used in clinical practice at UT Southwestern.

    • Titanium implants, pacemakers
    • Poorly controlled diabetes
    • Body weight greater than 300 pounds
    • Claustrophobic

  • Since each patient is receiving a gadolinium based contrast agent intravenously:

    • eGFR < 45 mL/min/1.73m2
    • Sickle cell disease
    • Hemolytic anemia
Contacts and Locations
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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): NCT02095808


Contacts
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Contact: Jeffery Wilson 214-648-7097 Jeffery.Wilson@utsouthwestern.edu

Locations
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United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Jeffery Wilson    214-648-7097    Jeffery.Wilson@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Kemp H Kernstine, MD University of Texas Southwestern Medical Center
More Information
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Responsible Party: Kemp Kernstine, PROFESSOR, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02095808    
Other Study ID Numbers: STU 052012-065
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: January 10, 2023
Last Verified: January 2023
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases