200 Participants Needed

Imaging Biomarkers for Lung Cancer

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JW
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Overseen ByEbele Mbanugo, Ed.D, CCRP
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how lung tumors use sugar for energy, using magnetic resonance imaging (MRI) technology. Participants will receive a special sugar solution through an IV during surgery, allowing researchers to track how the tumor processes sugar. The research focuses on improving imaging techniques, known as imaging biomarkers, to better understand lung cancer. Individuals with a suspected or confirmed lung tumor requiring surgical removal might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future lung cancer diagnostics.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have poorly controlled diabetes, you may not be eligible to participate.

What prior data suggests that this method is safe for evaluating lung tumors?

Research has shown that imaging tools like MRI are generally safe for people. Early results from studies using a special type of MRI called hyperpolarized 13C-MRI, which involves a special sugar, have demonstrated its safety and practicality for patients with various cancers, such as prostate and breast cancer. These studies reported no major safety concerns.

The 13C-glucose used in the study is a slightly altered sugar solution administered through an IV. While specific side effects for this study are not detailed, its use in a trial indicates it has passed safety checks in earlier tests. Prospective participants should discuss any safety concerns or questions with the research team.12345

Why are researchers excited about this trial?

Researchers are excited about the Imaging Biomarkers for Lung Cancer trial because it has the potential to transform how we detect and understand lung cancer during surgery. Unlike traditional methods that rely on visual assessment and pathology, this approach uses a 13C-glucose solution administered intravenously. This unique method allows surgeons to see metabolic activity in real-time, providing a more precise picture of tumor tissue. This could lead to more accurate removal of cancerous tissue and possibly improve surgical outcomes, offering a new level of precision in lung cancer treatment.

What evidence suggests that this MRI method is effective for evaluating lung tumors?

Research has shown that special imaging techniques can help evaluate lung cancer. In this trial, participants will receive a 13C-glucose solution intravenously during surgery to assess treatment effectiveness. MRI scans provide clear images of lung tumors and reveal how they use sugar to grow. This method uses a special sugar solution to observe tumor energy use, potentially aiding in planning better treatments. Evidence suggests these imaging techniques could improve treatment outcomes for lung cancer patients.26789

Who Is on the Research Team?

KH

Kemp H Kernstine, MD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with known or suspected malignant lung lesions that need surgical removal. It's open to all races and ethnicities. People with poorly controlled diabetes or those who are not suitable for surgery cannot participate.

Inclusion Criteria

I need surgery to remove or biopsy a suspected cancerous lesion.
I am over 18 years old.

Exclusion Criteria

My diabetes is not well-managed.
I cannot undergo surgery for my condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Imaging

Participants undergo DCE-MRI to determine eligibility for the [U-13C] glucose infusion

Within 5 days of scheduled surgery
1 visit (in-person)

Surgery and Infusion

Participants receive 13C-glucose solution intravenously during surgery for tumor removal

2-3 hours
1 visit (in-person)

Follow-up

Participants are monitored for metabolic alterations using C-13 isotopomer analysis and metabolomics

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Imaging Biomarkers
Trial Overview The study aims to use MRI scans, along with a special sugar solution (13C-glucose), to understand how lung tumors metabolize sugar. Researchers will analyze tumor samples post-surgery to learn about the metabolic pathways of cancer growth.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: SurgeryExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Published Research Related to This Trial

A unique radiogenomic dataset was developed from 211 patients with Non-Small Cell Lung Cancer (NSCLC), combining medical imaging data (CT and PET/CT) with genetic and clinical information to enhance understanding of tumor characteristics.
This dataset aims to improve patient care by facilitating the discovery of relationships between tumor molecular features and imaging biomarkers, potentially leading to better prognostic tools in precision medicine.
A radiogenomic dataset of non-small cell lung cancer.Bakr, S., Gevaert, O., Echegaray, S., et al.[2019]
In a study of 208 patients with primary malignancy, 89 small lung nodules were detected only on PET/CT and missed on PET/MRI, indicating that PET/MRI has lower sensitivity for these nodules.
Follow-up imaging showed that 97% of the missed nodules were stable or resolved, suggesting they are likely benign, which supports the use of PET/MRI as a viable imaging option in oncology despite its limitations.
Outcome of small lung nodules missed on hybrid PET/MRI in patients with primary malignancy.Raad, RA., Friedman, KP., Heacock, L., et al.[2022]
Imaging studies are crucial for diagnosing cancer, but they can sometimes yield inconclusive results, highlighting the need for additional diagnostic methods.
Integrating biomarkers with imaging techniques may enhance the diagnostic process and improve patient management in cancer care.
Integration of biomarkers and imaging.Patz, EF.[2016]

Citations

Biomarkers in lung cancer screening: achievements ...The present review is an update of the research and development efforts regarding the use of molecular biomarkers in the lung cancer screening setting.
Quantitative Imaging Biomarkers in Lung CancerCompared to chest radiography, low-dose chest computed tomography (CT) is more effective in detecting early-stage lung cancers, though it does ...
Imaging Biomarkers for Immune Checkpoint Inhibitor ...Purpose: To evaluate the association between metabolic imaging parameters measured by F-18 FDG PET/CT and clinical outcomes in patients with non-small cell lung ...
Imaging Biomarkers for Lung CancerThis suggests that imaging biomarkers can be effective in evaluating and potentially improving treatment outcomes for lung cancer.
Imaging Biomarkers to Predict and Evaluate the ...We aimed to identify imaging biomarkers to assess predictive capacity of radiomics nomogram regarding treatment response status (responder/non-responder) in ...
NCT02095808 | Metabolic Biomarkers in Thoracic CancersThe purpose of this research study is to develop a method of using magnetic resonance imaging (MRI) to evaluate lung tumors and other thoracic malignancies.
Association of circulating metabolic biomarkers with risk of ...A total of 109 metabolic biomarkers (30 metabolites and 79 lipoprotein subfractions) were associated with the risk of lung cancer.
Imaging of glucose metabolism by 13C-MRI distinguishes ...We demonstrate that tumor xenografts with a similar genetic background can be distinguished by their differing rates of the metabolism of 13C labeled glucose ...
The use of hyperpolarised 13C-MRI in clinical body ...The first translational studies have demonstrated the safety and feasibility of the technique in patients with prostate, renal, breast and ...
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