This phase I trial tests whether 18F-FAraG positron emission tomography (PET)/computed tomography (CT) scans can find tumors and predict response to treatment in patients with esophageal cancer that has spread to nearby tissue or lymph nodes (locally advanced). 18F-FAraG is an imaging tracer that is used to visualize tumors using a PET scan. A PET scan uses radioactive material injected into the blood to show the internal workings of the body. A CT scan uses x-rays and a computer to produce a 3-dimensional image of the body. Combining the two scans may help doctors better understand the extent and the exact location of disease. Diagnostic procedures, such as 18F-FAraG PET/CT, may help detect tumors and predict treatment response in patients with locally advanced esophageal cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06414902.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Steven H. Lin
Phone: 713-563-8490
PRIMARY OBJECTIVES:
I. Evaluate the ability of fluorine F 18 Ara-G (18F-FAraG) PET imaging to detect tumors in patients with esophageal cancer.
II. Evaluate 18F-FAraG PET as a predictor of pathologic complete response.
SECONDARY OBJECTIVES:
I. Evaluate the correlation of 18F-FAraG PET with clinical characteristics.
II. Evaluate the correlation of 18F-FAraG PET with single-cell ribonucleic acid sequencing (scRNA-seq) data.
III. Evaluate tissue and blood biomarkers as predictors of treatment response and disease recurrence.
IV. Evaluate functional imaging with 18F-FAraG PET and tissue and blood biomarkers as predictors of overall survival and disease-free survival.
V. Compare 18F-FAraG PET standardized uptake value (SUV) update to the change in standard fludeoxyglucose F-18 (18FDG)-PET SUV parameters before and after chemoradiation.
OUTLINE:
Patients receive 18F-FAraG intravenously (IV) over 65 minutes and undergo PET/CT. Patients also undergo standard of care (SOC) 18FDG PET/CT at baseline and follow-up.
After completion of study intervention, patients are followed up at 1-30 days and 90 days.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorSteven H. Lin