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

NCT00603057 | Completed DMC

• 2 other identifiers: UMCC 2006.040HUM00002913
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer

Outcome Measures

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.

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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Lung cancer patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Shruti Jolly, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2008
• First Posted: January 28, 2008
• Study Start: May 1, 2007
• Primary Completion: September 1, 2013
• Study Completion: March 1, 2015
• Last Updated: October 14, 2019

Record last verified: 2019-10

Locations

US (1)