Imaging Biomarkers for Lung Cancer

Overseen By Ebele Mbanugo, Ed.D, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Poorly controlled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

200 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 6 7 8 9}

Who Is on the Research Team?

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?

Group I: Surgery Experimental Treatment 1 Intervention

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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integration of biomarkers and imaging. Patz, EF.[2016]

A new imaging signature developed from PET/CT scans can effectively predict progression-free survival (PFS) in patients with locally advanced non-small cell lung cancer (NSCLC), based on a study of 82 patients treated with chemoradiotherapy.

This imaging signature, which includes features like baseline tumor volume and distances between tumors and lymph nodes, stratified patients into low- and high-risk groups for disease progression, showing significant improvement over traditional imaging metrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early response evaluation using primary tumor and nodal imaging features to predict progression-free survival of locally advanced non-small cell lung cancer. Zhang, N., Liang, R., Gensheimer, MF., et al.[2021]

Imaging techniques, particularly chest radiographs and thoracic computed tomography, are crucial for diagnosing and staging lung cancer, helping to identify tumors and assess local disease.

Whole body positron emission tomography (PET) has emerged as a valuable tool for evaluating lung cancer, providing comprehensive insights into the primary tumor and potential metastases, which may lead to improved survival rates with advancements in imaging and treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging lung cancer. Patz, EF.[2005]

New imaging techniques, particularly digital radiography with postprocessing and low-dose CT, show promise in effectively detecting lung cancer beyond the limitations of traditional chest radiography.

Advanced imaging methods like MRI and PET can enhance clinical staging by providing detailed information on tumor characteristics, including calcifications, vascularization, and metabolic activity, which are crucial for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Bronchial carcinoma: new radiologic methods]. Vock, P.[2006]

Positron emission tomography (PET) is a highly effective imaging technique for diagnosing, staging, and restaging lung cancer, offering better detection efficiency compared to traditional gamma camera devices.

The combination of PET with computed tomography (CT) into a hybrid PET-CT system enhances both metabolic and anatomical imaging, potentially improving treatment pathways and outcomes for lung cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET and SPECT in the management of lung cancer. Sarinas, PS., Chitkara, RK.[2019]

Microscopic resolution MRI successfully identified and characterized hepatic neoplasms in a live rat model, allowing for the detection of lesions smaller than 3 mm in diameter, which is significant for toxicologic research.

The study demonstrated that longer T2 relaxation times in MRI images corresponded with the presence of liver lesions, indicating that late-echo images provide clearer visualization of these abnormalities compared to early-echo images.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging of hepatic neoplasms in the rat. Johnson, GA., Thompson, MB., Cofer, GP., et al.[2017]

Recent advancements in pulmonary magnetic resonance (MR) imaging have improved its ability to provide accurate and quantitative evaluations of lung cancer, potentially making it a substitute for traditional nuclear medicine examinations.

MR imaging can effectively characterize solitary pulmonary nodules and assess various aspects of lung cancer, including metastasis and pulmonary function, suggesting it could enhance patient management in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR imaging of lung cancer. Ohno, Y., Sugimura, K., Hatabu, H.[2019]

Imaging biomarkers are crucial in cancer management as they provide objective insights into tumor biology and response to treatments, enhancing the personalized approach of precision cancer medicine.

This review highlights the importance of developing imaging biomarkers, particularly through magnetic resonance imaging (MRI), to complement genomic and molecular diagnostics in understanding and treating cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging biomarkers in oncology: Basics and application to MRI. Dregely, I., Prezzi, D., Kelly-Morland, C., et al.[2021]

Lung cancer is the leading cause of cancer-related deaths worldwide, highlighting the critical role of imaging in its management.

Key imaging techniques such as chest radiography, CT, MRI, and PET are essential for various stages of lung cancer care, and emerging technologies like artificial intelligence and radiomics may enhance imaging capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging of lung cancer. Madani, MH., Riess, JW., Brown, LM., et al.[2023]

Recent advancements in MR imaging techniques have improved its effectiveness for evaluating lung cancer, including better detection of pulmonary nodules and assessment of lung masses.

MR imaging is now recognized and reimbursed by health insurance in many countries, indicating its growing acceptance and utility in clinical practice for lung cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update of MR Imaging for Evaluation of Lung Cancer. Ciliberto, M., Kishida, Y., Seki, S., et al.[2018]

Quantitative imaging techniques, such as 18F-FDG PET/CT-derived standard uptake values (SUV), are enhancing the diagnosis, staging, and treatment response evaluation in lung cancer, moving beyond traditional qualitative assessments.

Emerging methods like CT volumetric assessments and radiomics are expected to improve accuracy in lung cancer imaging, reducing variability and providing better prognostic insights through advanced data analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in Imaging and Automated Quantification of Malignant Pulmonary Diseases: A State-of-the-Art Review. Hochhegger, B., Zanon, M., Altmayer, S., et al.[2022]

Dynamic MRI can effectively differentiate between local control and local failure in non-small-cell lung cancer (NSCLC) patients after chemoradiotherapy, with significant differences in the maximum relative enhancement ratio and slope of enhancement between the two groups.

Using a threshold slope of enhancement of 0.08/sec, dynamic MRI demonstrated high sensitivity (90.9%) and specificity (91.3%) for predicting patient outcomes, with lower slopes correlating with longer survival times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic value of dynamic MR imaging for non-small-cell lung cancer patients after chemoradiotherapy. Ohno, Y., Nogami, M., Higashino, T., et al.[2022]

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