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Using Functional Image and Circulating Molecular Markers to Predict Tumor Response and Lung Toxicity in Treatment of Lung Cancer

Phase 2
18 Years
Open (Enrolling)
Non-Small Cell Lung Cancer

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Trial Information

Using Functional Image and Circulating Molecular Markers to Predict Tumor Response and Lung Toxicity in Treatment of Lung Cancer

Lung cancer is the leading cause of cancer deaths in the United States, of which 80% are
lung cancer (NSCLC, including squamous cell lung cancer, and small cell lung cancer).
Although surgery provides the best chance of cure, the majority of lung cancer require
radiation for treatment. The current radiation recommendation, using modern techniques and a
uniform radiation dose, 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) provides a useful tool to monitor, but a 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 changes in tumor activity and regional lung function
during the course of radiation, which may be associated with long-term outcome. The general
strategy of this project is to perform functional image and blood test during the course of
radiation and correlate them with long-term outcomes. By completing this study, we expect to
generate predictive models better than CT-based ones for both tumor control and lung

Inclusion Criteria:

- Histologically confirmed NSCLC or clinically diagnosed NSCLC providing that FDG-PET
is positive.

- Stage I to III lung cancer requiring definitive irradiation with or without

- 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

- Patients must sign an informed consent form for study.

Exclusion Criteria:

- Small cell lung cancer or mixed small cell/non-small cell histology

- 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 (approximately 45
minutes for each study)

- Prisoners are excluded from this study.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

The primary aim of this study is to investigate predictive models for long-term tumor control and late treatment lung toxicity by using FDG-PET-CT, V/Q SPECT-CT and blood tests during the course of radiation therapy.

Outcome Time Frame:

During treatment with radiation at 40-50 Gy and up to 5 yrs after radiation completed

Safety Issue:


Principal Investigator

Feng-Ming Kong, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan


United States: Institutional Review Board

Study ID:

UMCC 2006.040



Start Date:

May 2007

Completion Date:

May 2015

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



University of Michigan Ann Arbor, Michigan  48109-0624