TerminatedNot applicableNCT02117440

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

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.

Checked against the public recordLast updated Feb 25, 2019 · Source: ClinicalTrials.gov

StatusTerminated
PhaseNot applicable
U.S. locations1
SponsorIndiana University
01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Indiana University
Interventions being studied
Not specified
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Potentially eligible patients include all patients with stage I to IV lung cancer. Patient cannot have started systemic treatments or radiation treatments prior to enrollment on the study. Informed consent will be obtained in writing prior to initiating the study using a consent form approved by the local IRB. Inclusion criteria * 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 Exclusion criteria * 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)

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Indiana University Simon Cancer CenterIndianapolis, Indiana

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 25, 2019. Always confirm current availability with the study team.

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