A Phase 1/2 interventional study of Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside and Computed Tomography in Lung Adenocarcinoma, sponsored by Jonsson Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-10.
Sponsored by Jonsson Comprehensive Cancer Center · Phase 1/2, Interventional, and Diagnostic
The phase I/II trial assess the safety and efficacy of a new positron emission tomography (PET) test for early diagnosis of lung cancer. This study uses PET and Me-4FDG new glucose tracer (alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside) designed specifically to determine glucose update into cells in the body. PET is a non-invasive imaging method used to detect cancer in patient. Me4FDG is a radioactive glucose tracer used in PET to locate cells in the body taking up glucose by SGLT2. SLGT2 is a sodium glucose transport protein that accumulates glucose in some cells, e.g. kidney cells and tumors. This study may help researcher determine how effective PET with ME4FDG tracer works in detecting lung cancer.
PRIMARY OBJECTIVE:
I. Assess the safety and efficacy of alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside (Me-4FDG) for early diagnosis of lung cancer.
SECONDARY OBJECTIVE:
I. Evaluate the correlation of Me-4FDG positivity with histopathological features of the disease (tumor grade, expression of sodium-glucose cotransporter-2 inhibitors.(SGLT2).
OUTLINE:
Patients receive Me-4FDG tracer intravenously (IV) and then undergo PET/CT over 15 minutes.
After completion of study , patients are followed up at 7 days.
303 studies on the registry are indexed under Adenocarcinoma of Lung; 78 are open to participants now.
This study's planned enrollment of 60 is close to the median of 63 across 212 interventional studies indexed under Adenocarcinoma of Lung.
Browse Adenocarcinoma of Lung studies →Jonsson Comprehensive Cancer Center is the lead sponsor of 396 studies on the registry; 67 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive Me-4FDG tracer IV and then undergo PET/CT over 15 minutes.
Drug: Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside · Procedure: Computed Tomography · Other: Laboratory Biomarker Analysis · Procedure: Positron Emission Tomography
Given IV
Also known as: a-methyl-4[18F]-4-deoxy-D-glucopyranoside, Alpha-methyl-4-[F-18]-fluoro-4-deoxy-d-glucopyranoside, Me-4(18F)DG, Me-4FDG, Me4FDG, METHYL 4-DEOXY-4-FLUORO-.ALPHA.-D-GLUCOPYRANOSIDE. F-18
Undergo PET/CT
Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Correlative studies
Undergo PET/CT
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Sensitivity of Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside (Me-4FDG) positron-emission tomography (PET) scans
Will be determined by calculating the standardized uptake value (SUV) in the lesions and the contrast to noise ratio (CNR) relative to an area of normal lung surrounding the lesion, and evaluated by assessing the percentage of patients with a pathologic diagnosis of lung cancer that results positive at Me-4FDG PET scans.
Time frame: within one month of surgery or biopsy
Specificity of Me-4FDG for lung cancer
Will be estimated by the percentage of Me-4FDG negativity in lung nodules that have been determined radiologically and/or clinically to be benign with a lung-RAD (Lung Imaging Reporting and Data System), score 1-3.
Time frame: within one week of experimental PET/CT scan
Optimal combination of sensitivity and specificity
Will combine SUV and CNR cut-points that yield the optimal combination of sensitivity (positivity within the adenocarcinoma group) and specificity (negativity with the benign group). Optimality will be based on the cut-points that maximize the Youden index (sum of the sensitivity plus specificity). Based on the combined cut point, will construct 95% confidence intervals for the sensitivity and specificity.
Time frame: within one week of experimental PET/CT scan
Incidence of adverse events of Me-4FDG
Will tabulate the number of adverse events (AEs) and the severity of adverse events (SAEs) for the overall population as well as within subjects.
Time frame: From baseline to one week after Me-4FDG administration
Efficacy of Me-4FDG in diagnosing lung cancer
Will be evaluated by measuring the percentage of test positivity in patients with a pathological diagnosis of lung cancer.
Time frame: within one week of the experimental PET/CT scan
Correlation of Me-4FDG positivity with histopathological features (tumor grade)
Ordinal logistic regression will be used to assess the correlation between Me-4FDG uptake and tumor grade.
Time frame: within one month of surgery or biopsy
Correlation of Me-4FDG positivity with histopathological features (expression of SGLT2)
Will be evaluated experimentally with validated specific antibodies.
Time frame: within two months of surgery or biopsy
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Jonsson Comprehensive Cancer Center