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An Investigational Scan (Me-4FDG PET/CT) for the Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cancer

NCT05558904 · Jonsson Comprehensive Cancer Center
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Official title
Positron-Emission Tomography Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cancer
About this study
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.
Eligibility criteria
Inclusion Criteria: * Age \> 18 years * Lung nodule \>= 1 cm visualized by CT imaging * CANCER ARM: Pathologically confirmed lung adenocarcinoma. For patients who are surgical candidates, the pathologic report on the surgical specimen will confirm the diagnosis. For patients who are not surgical candidates, the enrollment will be contingent upon a pathologic diagnosis of lung cancer obtained by needle biopsy * BENIGN ARM: Lung nodules considered to be clinically benign, according to the Guidelines for Management of Incidental Pulmonary Nodules from the Fleischner Society. Will consider "benign" the nodules with a lung-RADS score of 1-3 Exclusion Criteria: * Pregnancy * Diagnosis of diabetes * Current treatment with SGLT2 inhibitors or metformin
Study design
Enrollment target: 60 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-01-19
Estimated completion: 2027-10-01
Last updated: 2025-11-10
Interventions
Drug: Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranosideProcedure: Computed TomographyOther: Laboratory Biomarker AnalysisProcedure: Positron Emission Tomography
Primary outcomes
  • Sensitivity of Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside (Me-4FDG) positron-emission tomography (PET) scans (within one month of surgery or biopsy)
  • Specificity of Me-4FDG for lung cancer (within one week of experimental PET/CT scan)
  • Optimal combination of sensitivity and specificity (within one week of experimental PET/CT scan)
Sponsor
Jonsson Comprehensive Cancer Center · other
With: LUNGevity Foundation, American Cancer Society, Inc.
Contacts & investigators
ContactYesenia Calzada · contact · YCalzada@mednet.ucla.edu · 424.946.5026
InvestigatorClaudio Scafoglio, MD, PhD · principal_investigator, UCLA / Jonsson Comprehensive Cancer Center
All locations (1)
Yesenia CalzadaRecruiting
Los Angeles, California, United States
An Investigational Scan (Me-4FDG PET/CT) for the Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cancer · TrialPath