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NCT Number: NCT05558904

An Investigational Scan (Me-4FDG PET/CT) for the 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.

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Key information

Conditions

Lung Adenocarcinoma Adenocarcinoma Adenocarcinoma of Lung Carcinoma Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Yesenia Calzada

Los Angeles, California, 90095, United States

Location status: Recruiting

Location contact

Claudio Scafoglio, MD, PhD

PRINCIPAL_INVESTIGATOR

Yesenia Calzada

CONTACT

[email protected]

424-946-5026

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside

Drug

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

Computed Tomography

Procedure

Undergo PET/CT

Other names: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

laboratory biomarker analysis

Other

Correlative studies

Positron Emission Tomography

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yesenia Calzada

CONTACT

[email protected]

424.946.5026

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Collaborators

  • American Cancer Society, Inc.
  • LUNGevity Foundation

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Sep 28, 2022
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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