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

November 6, 2025 updated by: Jonsson Comprehensive Cancer Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Yesenia Calzada
        • Contact:
        • Principal Investigator:
          • Claudio Scafoglio, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (Me-4FDG PET/CT)
Patients receive Me-4FDG tracer IV and then undergo PET/CT over 15 minutes.
Other: Laboratory Biomarker Analysis
Correlative studies
Procedure: Computed Tomography
Undergo PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
Drug: Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside
Given IV
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optimal combination of sensitivity and specificity
Time Frame: within one week of experimental PET/CT scan
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
Time Frame: From baseline to one week after Me-4FDG administration
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
Time Frame: within one week of the experimental PET/CT scan
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
Sensitivity of Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside (Me-4FDG) positron-emission tomography (PET) scans
Time Frame: within one month of surgery or biopsy
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
Time Frame: within one week of experimental PET/CT scan
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of Me-4FDG positivity with histopathological features (tumor grade)
Time Frame: within one month of surgery or biopsy
Ordinal logistic regression will be used to assess the correlation between Me-4FDG uptake and tumor grade.
within one month of surgery or biopsy
Correlation of Me-4FDG positivity with histopathological features (expression of SGLT2)
Time Frame: within two months of surgery or biopsy
Will be evaluated experimentally with validated specific antibodies.
within two months of surgery or biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

American Cancer Society, Inc.
LUNGevity Foundation

Investigators

  • Principal Investigator: Claudio Scafoglio, MD, PhD, UCLA / Jonsson Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

September 12, 2022

First Submitted That Met QC Criteria

September 23, 2022

First Posted (Actual)

September 28, 2022

Study Record Updates

Last Update Posted (Estimated)

November 10, 2025

Last Update Submitted That Met QC Criteria

November 6, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-000027
  • NCI-2022-06770 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Adenocarcinoma

Clinical Trials on Laboratory Biomarker Analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe