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Imaging Biomarkers for Lung Cancer

N/A

Recruiting

Led By Kemp H Kernstine, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have known or probable malignant lesions requiring surgical biopsy or excision.

Be older than 18 years old

Must not have

Poorly controlled diabetes.

Not a surgical candidate.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at using MRI to study how a mass in the lung metabolizes sugar.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves standard MRI imaging and analysis of surgically removed tissue, there are no direct side effects from drugs being tested; however, typical risks associated with MRIs and surgeries apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need surgery to remove or biopsy a suspected cancerous lesion.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My diabetes is not well-managed.

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I cannot undergo surgery for my condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

DCE-MRI

Secondary study objectives

C-13 isotopomer

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SurgeryExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Imaging Biomarkers

2021

N/A

~50

0 / 3Eligibility criteria met