Metabolic Biomarkers in Thoracic Cancers
1 other identifier
interventional
200
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable lung-cancer
Started Mar 2013
Longer than P75 for not_applicable lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 20, 2013
CompletedFirst Submitted
Initial submission to the registry
April 17, 2013
CompletedFirst Posted
Study publicly available on registry
March 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
May 1, 2026
April 1, 2026
13.8 years
April 17, 2013
April 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
DCE-MRI
Physicians and researchers will review the results of the imaging to determine if the patient will receive the \[U-13C\] glucose infusion.
One time - within 5 days of the scheduled surgery
Secondary Outcomes (1)
C-13 isotopomer
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.
Study Arms (1)
Surgery
EXPERIMENTALThe 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.
Interventions
Want to see if using 13C-glucose helps in detecting cancer and deciding on a treatment plan.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Not a surgical candidate.
- Poorly controlled diabetes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kemp H Kernstine, MD
University of Texas Southwestern Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PROFESSOR
Study Record Dates
First Submitted
April 17, 2013
First Posted
March 26, 2014
Study Start
March 20, 2013
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
May 1, 2026
Record last verified: 2026-04