Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Functional Image and Molecular Markers to Predict Treatment Outcomes in Lung Cancer

Summary: This study is designed to apply functional imaging, Fluorodeoxyglucose_Positron Emission Tomography (FDG-PET) and Ventilation/Perfusion Single Photon Emission Computerized Tomography (V/Q SPECT), before treatment and then again during treatment to see if it predicts how well the treatment works for your cancer and how well your lungs function during treatment. A Computerized Tomography (CT) will also be performed along with both of these procedures to help the researchers see clearly where your cancer or your healthy lung is located. The researchers also perform blood tests in this study to look for markers in your blood to see if it helps them determine your risk of developing side effects from radiation to the lungs. The researchers hope that this study will help them in the future to design radiation treatment plans that provide the best treatment for each individual patient.

Detailed description: Lung cancer is the leading cause of cancer deaths in the United States. Although surgery provides the best chance of cure, the majority of lung cancers require radiation for treatment. The current radiation recommendation, using modern techniques and a uniform dose of prescription, generates an overall cure rate of less than 10-15%, and moderate toxicity in 10-30% of treated patients. Who can be cured and who will develop side effects? Computed tomography (CT) is a useful monitoring tool, but has limited power to predict both tumor control and lung toxicity. Using [18F] fluorodeoxyglucose positron emission tomography (FDG-PET) and ventilation/perfusion single photon emission computed tomography (V/Q SPECT), we have recently shown heterogeneous changes in tumor activity and regional lung function during the course of radiation, which may be associated with long-term outcome. Data have also shown that radiation up-regulates the expression of cytokines, such as transforming growth factor beta 1 (TGFß1) and interleukin-6 (IL-6). We hypothesize that radiation-induced functional changes and plasma cytokines are associated with long-term tumor control and radiation lung damage. The general strategy of this protocol is to perform functional imaging and blood testing during the course of radiation and correlate the results with long-term outcomes.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed lung cancer, or clinically diagnosed lung cancer plus positive FDG-PET
  -  AJCC Stage I to IV lung cancer requiring radiation therapy (3D conformal or stereotactic) with or without chemotherapy, palliative radiation needing dose up to 36 to 50 Gy, with or without surgery. Stage IV disease is eligible only if the patient has a solitary distant metastasis or lung nodules on the other lobes.
  -  Patients with a locoregional tumor recurrence following surgery will be eligible provided they meet other eligibility criteria.
  -  Patients must be 18 years of age or older. Female patients with reproductive capability must be willing to use effective contraception
  -  Patients must be willing and able to be compliant with all procedures and visits required for this protocol (pre-treatment, during RT, and throughout follow up period).
  -  Patients must sign an informed consent form for study.
  Exclusion Criteria:
  -  Malignant pleural or pericardial effusion.
  -  Pregnancy
  -  Lactation
  -  Patients with diabetes mellitus, with uncontrolled fasting blood glucose level (above 200 mg/dl)
  -  Inability to lie flat for the duration of PET-CT and V/Q SPECT-CT (approximately 45 minutes for each study)
  -  Prisoners are excluded from this study.

Relevance to patient case: not relevant