NCT05558904

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

Positron-Emission Tomography Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lung Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside	Given IV
PROCEDURE	Computed Tomography	Undergo PET/CT
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Positron Emission Tomography	Undergo PET/CT

Timeline

• Start date: 2023-01-19
• Primary completion: 2026-10-01
• Completion: 2027-10-01
• First posted: 2022-09-28
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study