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
2 other identifiers
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2023
Longer than P75 for phase_1
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
First Submitted
Initial submission to the registry
September 12, 2022
CompletedFirst Posted
Study publicly available on registry
September 28, 2022
CompletedStudy Start
First participant enrolled
January 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
November 10, 2025
September 1, 2025
3.7 years
September 12, 2022
November 6, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
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.
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.
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.
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.
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.
within one week of the experimental PET/CT scan
Secondary Outcomes (2)
Correlation of Me-4FDG positivity with histopathological features (tumor grade)
within one month of surgery or biopsy
Correlation of Me-4FDG positivity with histopathological features (expression of SGLT2)
within two months of surgery or biopsy
Study Arms (1)
Diagnostic (Me-4FDG PET/CT)
EXPERIMENTALPatients receive Me-4FDG tracer IV and then undergo PET/CT over 15 minutes.
Interventions
Given IV
Undergo PET/CT
Undergo PET/CT
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy
- Diagnosis of diabetes
- Current treatment with SGLT2 inhibitors or metformin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jonsson Comprehensive Cancer Centerlead
- LUNGevity Foundationcollaborator
- American Cancer Society, Inc.collaborator
Study Sites (1)
Yesenia Calzada
Los Angeles, California, 90095, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claudio Scafoglio, MD, PhD
UCLA / Jonsson Comprehensive Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2022
First Posted
September 28, 2022
Study Start
January 19, 2023
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2027
Last Updated
November 10, 2025
Record last verified: 2025-09