Functional Image and Molecular Markers to Predict Treatment Outcomes in Lung Cancer

NCT02117440 | Terminated DMC

• 2 other identifiers: IUSCC-0596GRU CC-13-24C
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to apply various scans such as functional imaging, Fluorodeoxyglucose\_Positron Emission Tomography (FDG-PET), 62Cu-ETS (Copper) PET, Ventilation/Perfusion Single Photon Emission Computerized Tomography (V/Q SPECT), cardiac magnetic resonance imaging (MRI), Tc-99m HMPAO SPECT/CT, and pulmonary function tests before, during and after treatment to see if it predicts how well the treatment works for your cancer and how well your lungs function 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 also perform blood tests in this study to look for markers in your blood to see if it helps them determine your risk of developing side effects from radiation to the lungs. They will also measure your health-related quality of life before, during and after treatment. 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

Lung Neoplasms

Keywords

Lung Cancer; Lung Neoplasms

Outcome Measures

Primary Outcomes (1)

• Investigate predictive models for long-term tumor control and late treatment lung toxicity by using FDG-PET-CT, V/Q SPECT-CT and blood test during the course of radiation therapy.

  Investigate predictive models for long-term tumor control and late treatment lung toxicity by using FDG-PET-CT, V/Q SPECT-CT and blood test during the course of radiation therapy. As secondary analysis, demographic and baseline clinical variables will be added to the model to determine if they add predictive value.

  Up to 5 years after radiation completion

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 lung cancer, or clinically diagnosed lung cancer.
• AJCC stage I to IV lung cancer requiring radiation therapy (3D conformal or stereotactic) or systemic therapy, with or without surgery.
• Patients participating treatment trials including targeted therapy, experimental therapy or immunotherapy are also eligible.
• 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 and able to lie flat to obtain the functional scans or have blood access for blood samples
• Female patients with reproductive capability must be willing to use effective contraception.
• Patients must be willing and able to be compliant with all procedures and visits required for this protocol (pre-treatment, during treatment, and optionally throughout follow-up period).
• Patients must sign an informed consent form for study.
• Patients must be willing and able to adhere to a special low-carb diet 24-48 hours prior to and fast 8-12 hours prior to every 18F-FDG PET scan

You may not qualify if:

• Pregnancy if the patient is receiving radiation therapy
• Lactation if the patient is receiving radiation therapy
• 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/CT (approximately 45 minutes for each study)

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

buffy coat, plasma and serum samples

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Feng-Ming Kong, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiation Oncology

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 21, 2014
• Study Start: May 1, 2017
• Primary Completion: March 2, 2018
• Study Completion: March 2, 2018
• Last Updated: February 25, 2019

Record last verified: 2019-02

Locations

US (1)