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Lung AdenocarcinomaPhase 1/2NCT05558904

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

A Phase 1/2 study testing Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside, Computed Tomography and Laboratory Biomarker Analysis in people with Lung Adenocarcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Adenocarcinoma
What is being tested?
Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside, Computed Tomography and Laboratory Biomarker Analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
19 Jan 2023to 1 Oct 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Pregnancy
  • Diagnosis of diabetes
  • Current treatment with SGLT2 inhibitors or metformin

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yesenia Calzada contact

424.946.5026

YCalzada@mednet.ucla.edu

United States1 site, 1 recruiting

  • Yesenia Calzada

    Los Angeles, California, 90095

    Yesenia Calzada, 424-946-5026, YCalzada@mednet.ucla.edu

    Claudio Scafoglio, MD, PhD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

Being tested
Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside, Computed Tomography, Laboratory Biomarker Analysis, Positron Emission Tomography
Medical subject headings
Adenocarcinoma of Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called a-methyl-4[18F]-4-deoxy-D-glucopyranoside, Alpha-methyl-4-[F-18]-fluoro-4-deoxy-d-glucopyranoside, Me-4(18F)DG, Me-4FDG

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo PET/CT

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan

    Undergo PET/CT

Study groups in NCT05558904
Study groupRoleWhat they receive
Diagnostic (Me-4FDG PET/CT)ExperimentalPatients receive Me-4FDG tracer IV and then undergo PET/CT over 15 minutes.
Receives: Drug: Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside; Procedure: Computed Tomography; Other: Laboratory Biomarker Analysis; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: within one month of surgery or biopsy

  2. 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.

    Measured: within one week of experimental PET/CT scan

  3. 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.

    Measured: within one week of experimental PET/CT scan

  4. 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.

    Measured: From baseline to one week after Me-4FDG administration

  5. 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.

    Measured: within one week of the experimental PET/CT scan

Secondary outcomes (2)

  1. Correlation of Me-4FDG positivity with histopathological features (tumor grade)

    Ordinal logistic regression will be used to assess the correlation between Me-4FDG uptake and tumor grade.

    Measured: within one month of surgery or biopsy

  2. Correlation of Me-4FDG positivity with histopathological features (expression of SGLT2)

    Will be evaluated experimentally with validated specific antibodies.

    Measured: within two months of surgery or biopsy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2022
  2. Study start19 Jan 2023
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05558904
Sponsor's protocol ID
22-000027
Other IDs
NCI-2022-06770
Status last verified
Sep 2025
First submitted
12 Sep 2022
Last updated
10 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside, Computed Tomography and Laboratory Biomarker Analysis in people with Lung Adenocarcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yesenia Calzada (424.946.5026, YCalzada@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05558904.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.

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