Using Imaging and Molecular Markers to Predict Tumor Response and Lung Toxicity in Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00603057
Recruitment Status : Active, not recruiting
First Posted : January 28, 2008
Last Update Posted : October 12, 2017
Information provided by (Responsible Party):
University of Michigan Cancer Center

Brief Summary:

Successful treatment of non-small cell lung cancer with radiation therapy requires that the physicians determine exactly where the tumor is in your body and protect your normal tissue. 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 helps predict how well the treatment works for your cancer and how well your lung functions 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 are also doing blood tests in this study to look for markers in your blood and to see if it helps them in determining 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.

Condition or disease
Non-Small Cell Lung Cancer

Detailed Description:
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 toxicity.

Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Using Functional Image and Circulating Molecular Markers to Predict Tumor Response and Lung Toxicity in Treatment of Lung Cancer
Study Start Date : May 2007
Actual Primary Completion Date : September 2013
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Lung Cancer Imaging Patients
Adult patients (>18 years of age)with histologically confirmed or clinically diagnosed lung cancer who require radiation therapy, with or without surgery and with or without chemotherapy.

Primary Outcome Measures :
  1. 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. [ Time Frame: During treatment with radiation at 40-50 Gy and up to 5 yrs after radiation completed ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Lung cancer patients

Inclusion Criteria:

  • Histologically confirmed Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC) clinically diagnosed providing that FDG-PET is positive.
  • Stage I to III lung cancer requiring definitive irradiation with or without chemotherapy.
  • 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 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 (approximately 45 minutes for each study)
  • Prisoners are excluded from this study.

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 identifier (NCT number): NCT00603057

United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Cancer Center
Principal Investigator: Shruti Jolly, M.D. University of Michigan

Responsible Party: University of Michigan Cancer Center Identifier: NCT00603057     History of Changes
Other Study ID Numbers: UMCC 2006.040
HUM00002913 ( Other Identifier: University of Michigan Medical IRB )
First Posted: January 28, 2008    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017

Keywords provided by University of Michigan Cancer Center:
Non Small Cell Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms