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

NCT ID: NCT02117440

Last Updated: 2019-02-25

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2018-03-02

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.

Detailed Description

Primary aims:

1. To determine if tumor metabolic activity plus volume measured by 18F-FDG PET/CT and tissue/tumor perfusion measured by 62Cu-ETS-PET before and during treatment predicts CT tumor response 3 months after completion of treatment and 1 and 2 year local-regional progression-free survival.

2. To determine if functional imaging based lung dose-volume histograms (DVH) more accurately predict changes in diffusion capacity of lung for carbon monoxide (DLCO) compared to the DVH based on simulating CT. Degree of lung toxicity will also be documented by functional scans such as Tc-99m HMPAO imaging.

3. To determine if baseline level, or changes in blood markers such as TGFß1 measured during the course of radiation, predict changes in DLCO.

Conditions

Lung Neoplasms

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Tim Lautenschlaeger

Assistant Professor of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Feng-Ming Kong, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University Simon Cancer Center

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

GRU CC-13-24C

Identifier Type: OTHER

Identifier Source: secondary_id

IUSCC-0596

Identifier Type: -

Identifier Source: org_study_id