Feasibility Study Using Imaging Biomarkers in Lung Cancer

Study ID
STU 052012-065

Cancer Related

Healthy Volunteers

Study Sites

  • Clements University Hospital
  • UT Southwestern Ambulatory Services
  • Zale Lipshy University Hospital

Jessica Saltarski

Principal Investigator
Kemp Kernstine, M.D., Ph.D.

Official Title

Feasibility Study Using Imaging Biomarkers in Lung Cancer

Brief Overview

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.


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.

Participant Eligibility

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

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