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CompletedNCT00603057Updated Oct 14, 2019

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

An observational study in Non-Small Cell Lung Cancer, sponsored by University of Michigan Rogel Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-14.

Sponsored by University of Michigan Rogel Cancer Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
115
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Non-Small Cell Lung Cancer

Keywords

  • Non Small Cell Lung Cancer
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 115 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

University of Michigan Rogel Cancer Center is the lead sponsor of 316 studies on the registry; 46 are open to participants now.

Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
115 participants (actual)
Patient registry
No

Groups and 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.

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What researchers measure

Primary outcomes

  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

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Study locations

1 site
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00603057
Lead sponsor
University of Michigan Rogel Cancer Center
Responsible party
Sponsor
First posted
Jan 28, 2008
Start date
May 2007
Primary completion
Sep 2013
Completion
Mar 2015
Last update
Oct 14, 2019

Study contacts

Shruti Jolly, M.D.
principal investigator · University of Michigan

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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