- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02117440
Functional Image and Molecular Markers to Predict Treatment Outcomes in Lung Cancer
February 21, 2019 updated by: Tim Lautenschlaeger, Indiana University
Using Functional Image and Circulating Molecular Markers to Predict Tumor Control and Thoracic Toxicity in Treatment of 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.
Study Overview
Status
Terminated
Conditions
Detailed Description
Primary aims:
- 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.
- 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.
- To determine if baseline level, or changes in blood markers such as TGFß1 measured during the course of radiation, predict changes in DLCO.
Study Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University Simon Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Lung cancer patients
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: Up to 5 years after radiation completion
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Feng-Ming Kong, MD, Indiana University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2017
Primary Completion (ACTUAL)
March 2, 2018
Study Completion (ACTUAL)
March 2, 2018
Study Registration Dates
First Submitted
April 16, 2014
First Submitted That Met QC Criteria
April 17, 2014
First Posted (ESTIMATE)
April 21, 2014
Study Record Updates
Last Update Posted (ACTUAL)
February 25, 2019
Last Update Submitted That Met QC Criteria
February 21, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IUSCC-0596
- GRU CC-13-24C (OTHER: Georgia Regents University)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lung Neoplasms
-
UNC Lineberger Comprehensive Cancer CenterSivan Innovation Ltd.CompletedLung Cancer | Neoplasms, Lung | Pulmonary Neoplasms | Neoplasms, Pulmonary | Pulmonary Cancer | Cancer of LungUnited States
-
Baptist Health South FloridaWithdrawnLung Cancer | Lung TumorUnited States
-
Portsmouth Hospitals NHS TrustCompletedLung Cancer | Interstitial Lung DiseaseUnited Kingdom
-
Point TherapeuticsTerminatedCarcinoma, Non-Small-Cell Lung | Lung Cancer | Neoplasms, Lung | Neoplasms, PulmonaryUnited States
-
University of UtahRecruitingLung Cancer | Lung Neoplasms/DiagnosisUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedLung Carcinoma | Lung Neoplasm | Malignant Lung NeoplasmUnited States
-
Keimyung University Dongsan Medical CenterCompletedLung Cancer | Lung Diseases, Interstitial
-
Oliver JonasMassachusetts General HospitalCompletedLung Cancer | Lung TumorUnited States
-
C. R. BardCompleted
-
Azienda Sanitaria-Universitaria Integrata di UdineRecruitingLung Diseases | Lung Cancer | Lung Adenocarcinoma | Lung Transplant Rejection | Lung; Node | Lung TBItaly