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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00603057
First received: January 4, 2008
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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 Phase
Non-Small Cell Lung Cancer
Phase 2

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: May 2007
Estimated Study Completion Date: September 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Lung cancer patients

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603057

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Feng-Ming Kong, M.D. University of Michigan
  More Information

No publications provided

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00603057     History of Changes
Other Study ID Numbers: UMCC 2006.040, HUM00002913
Study First Received: January 4, 2008
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 16, 2014