Lung NeoplasmsNCT02117440
Functional Image and Molecular Markers to Predict Treatment Outcomes in Lung Cancer
An observational study of Lung Neoplasms, run by Indiana University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 2 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung cancer patients
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Neoplasms
- Keywords
- Lung Cancer, Lung Neoplasms
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 years after radiation completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study start1 May 2017
- Primary completion2 Mar 2018
- Study completion2 Mar 2018
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Lautenschlaeger, Indiana University
- Investigators
- Feng-Ming Kong, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117440
- Sponsor's protocol ID
- IUSCC-0596
- Other IDs
- GRU CC-13-24C
- Status last verified
- Feb 2019
- First submitted
- 16 Apr 2014
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Functional Image and Circulating Molecular Markers to Predict Tumor Control and Thoracic Toxicity in Treatment of Lung Cancer
- ClinicalTrials.gov ID
- NCT02117440
- Acronym / sponsor ID
- IUSCC-0596
- Conditions
- Lung Neoplasms
- Keywords
- Lung Cancer, Lung Neoplasms
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left institution
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 2 Mar 2018 (actual)
- Study completion
- 2 Mar 2018 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung cancer patients
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng-Ming Kong, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasms, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2019.