Lung CancerNCT02095808
Metabolic Biomarkers in Thoracic Cancers
A study testing Imaging Biomarkers in people with Lung Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this research study is to develop a method of using magnetic resonance imaging (MRI) to evaluate lung tumors and other thoracic malignancies. An MRI is a scanning device that uses magnets to make images (pictures) of the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Imaging Biomarkers
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2013to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patients must have known or probable malignant lesions requiring surgical biopsy or excision.
- Subjects of all races and ethnic origins over 18 years of age.
Who cannot join
- Not a surgical candidate.
- Poorly controlled diabetes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Ebele Mbanugo, Ed.D, CCRP, 214-648-7097, ebele.mbanugo@utsouthwestern.edu
About this study
The purpose of this research study is to develop a method of using magnetic resonance imaging (MRI) to evaluate lung tumors and other thoracic malignancies. An MRI is a scanning device that uses magnets to make images (pictures) of the body. This study is being done to determine what series of reactions (metabolic pathways) pulmonary nodules use as they burn sugar as fuel for growth. The manner in which the tumor burns (metabolizes) sugar for fuel is being investigated by using a natural, slightly modified, sugar solution (13C-glucose) and studying a small sample of the tumor once it is removed at the time of surgery.
Read the detailed description
The recent report of the findings of the National Lung Screening Trial indicates that screening a high-risk population using low dose CT results in a 20% reduction in lung cancer mortality. At our institution, some of positive nodules that are 1 cm or larger would be imaged using combined fluoro-deoxyglucose positron emission tomography (FDG PET)/CT. Highly suspicious nodules would be biopsied if the risks were manageable. Otherwise, the suspicious nodules not eligible for biopsy and so-called "indeterminate" nodules are followed using CT to be evaluated for interval growth.
The overall goal of this project is to assess several very promising imaging biomarkers that can reflect either the physiological or metabolic status of these nodules in order to develop more accurate imaging algorithms for follow-up that are either less invasive or do not use ionizing radiation or both. Based on our experience with other cancers and our preliminary results in lung cancer, we have identified four potential imaging studies that we believe have the potential to result in validated "imaging biomarkers" that can either individually, or in combination, characterize malignancies. Since tumors tend to exhibit angiogenesis and altered vascular permeability, we and others, have found that analyses of dynamic contrast enhanced MRI (DCEMRI) can be employed as "imaging biomarkers" for malignancy. Tumors often exhibit higher cellularity than benign or normal tissue suggesting that pixel-by-pixel ADC values derived from diffusion weighted MRI could be useful imaging biomarkers. Finally, measuring alterations in metabolic fluxes through the use of pathway specific C-13 labeled compounds, a technique pioneered here at the Advanced Imaging Research Center (AIRC) at UT Southwestern, has shown the capability of providing metabolic fingerprints for malignant and benign tissue. This approach, while invasive, could identify and validate markers that can be detected non-invasively in future studies. We will also employ advanced metabolomics methods to identify potential signature "onco-metabolites" in these lung cancers.
- Conditions
- Lung Cancer
- Being tested
- Imaging Biomarkers
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging BiomarkersProcedure or surgery
Want to see if using 13C-glucose helps in detecting cancer and deciding on a treatment plan.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | The 13C-glucose solution will be given intravenously. It will be started at about the same time as the start of surgery, according to the study guidelines.
The 13C-glucose IV solution will be stopped once the surgeon has removed the tumor tissue. Receives: Procedure: Imaging Biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
DCE-MRI
Physicians and researchers will review the results of the imaging to determine if the patient will receive the [U-13C] glucose infusion.
Measured: One time - within 5 days of the scheduled surgery
Secondary outcomes (1)
C-13 isotopomer
Employ C-13 isotopomer analysis and metabolomics on specimens obtained from resected tissue of suitable patients in this cohort to determine the metabolic alterations present in lung cancer.
Measured: During the infusion period blood samples will be collected every 30 minutes (for 2-3 hours) until the end of tumor sampling for mass spec and NMR analyisis of C-glucose in the blood.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study start20 Mar 2013
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kemp Kernstine, University of Texas Southwestern Medical Center
- Investigators
- Kemp H Kernstine, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095808
- Sponsor's protocol ID
- STU 052012-065
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2013
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Biomarkers in Thoracic Cancers
- ClinicalTrials.gov ID
- NCT02095808
- Acronym / sponsor ID
- STU 052012-065
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 20 Mar 2013 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Mar 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.
The purpose of this research study is to develop a method of using magnetic resonance imaging (MRI) to evaluate lung tumors and other thoracic malignancies. An MRI is a scanning device that uses magnets to make images (pictures) of the body. This study is being done to determine what series of reactions (metabolic pathways) pulmonary nodules use as they burn sugar as fuel for growth. The manner in which the tumor burns (metabolizes) sugar for fuel is being investigated by using a natural, slightly modified, sugar solution (13C-glucose) and studying a small sample of the tumor once it is removed at the time of surgery.
Detailed description
The recent report of the findings of the National Lung Screening Trial indicates that screening a high-risk population using low dose CT results in a 20% reduction in lung cancer mortality. At our institution, some of positive nodules that are 1 cm or larger would be imaged using combined fluoro-deoxyglucose positron emission tomography (FDG PET)/CT. Highly suspicious nodules would be biopsied if the risks were manageable. Otherwise, the suspicious nodules not eligible for biopsy and so-called "indeterminate" nodules are followed using CT to be evaluated for interval growth.
The overall goal of this project is to assess several very promising imaging biomarkers that can reflect either the physiological or metabolic status of these nodules in order to develop more accurate imaging algorithms for follow-up that are either less invasive or do not use ionizing radiation or both. Based on our experience with other cancers and our preliminary results in lung cancer, we have identified four potential imaging studies that we believe have the potential to result in validated "imaging biomarkers" that can either individually, or in combination, characterize malignancies. Since tumors tend to exhibit angiogenesis and altered vascular permeability, we and others, have found that analyses of dynamic contrast enhanced MRI (DCEMRI) can be employed as "imaging biomarkers" for malignancy. Tumors often exhibit higher cellularity than benign or normal tissue suggesting that pixel-by-pixel ADC values derived from diffusion weighted MRI could be useful imaging biomarkers. Finally, measuring alterations in metabolic fluxes through the use of pathway specific C-13 labeled compounds, a technique pioneered here at the Advanced Imaging Research Center (AIRC) at UT Southwestern, has shown the capability of providing metabolic fingerprints for malignant and benign tissue. This approach, while invasive, could identify and validate markers that can be detected non-invasively in future studies. We will also employ advanced metabolomics methods to identify potential signature "onco-metabolites" in these lung cancers.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Procedure: Imaging BiomarkersThe 13C-glucose solution will be given intravenously. It will be started at about the same time as the start of surgery, according to the study guidelines. The 13C-glucose IV solution will be stopped once the surgeon has removed the tumor tissue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must have known or probable malignant lesions requiring surgical biopsy or excision.
- Subjects of all races and ethnic origins over 18 years of age.
Key exclusion criteria (2 listed)
- Not a surgical candidate.
- Poorly controlled diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaging BiomarkersWant to see if using 13C-glucose helps in detecting cancer and deciding on a treatment plan. | Procedure or surgery | Surgery |
Primary outcome
DCE-MRI
Time frame: One time - within 5 days of the scheduled surgery
Physicians and researchers will review the results of the imaging to determine if the patient will receive the [U-13C] glucose infusion.
1 secondary outcome
C-13 isotopomer
Time frame: During the infusion period blood samples will be collected every 30 minutes (for 2-3 hours) until the end of tumor sampling for mass spec and NMR analyisis of C-glucose in the blood.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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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.
Kemp H Kernstine, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaging Biomarkers in people with Lung Cancer, run by University of Texas Southwestern Medical Center 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 1 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ebele Mbanugo, Ed.D, CCRP (214-648-7097, ebele.mbanugo@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DCE-MRI (time frame: One time - within 5 days of the scheduled surgery). 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 1 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.