Recruiting
Phase 1
Phase 2

Me-4FDG PET/CT

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT05558904

Conditions

Lung Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Computed Tomography

Laboratory Biomarker Analysis

Positron Emission Tomography

Study Details

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.

Conditions

Lung Adenocarcinoma

Study ID

NCT05558904

Start date

Jan 19, 2023

Status verified date

Sep, 2025

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnostic (Me-4FDG PET/CT)

Patients receive Me-4FDG tracer IV and then undergo PET/CT over 15 minutes.

Interventions

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

Given IV

Computed Tomography

Undergo PET/CT

Laboratory Biomarker Analysis

Correlative studies

Positron Emission Tomography

Undergo PET/CT

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 ]
  • Specificity of Me-4FDG for lung cancer [ Time Frame: within one week of experimental PET/CT scan ]
  • Optimal combination of sensitivity and specificity [ Time Frame: 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 ]
  • Efficacy of Me-4FDG in diagnosing lung cancer [ Time Frame: within one week of the experimental PET/CT scan ]

Central Contacts and Locations

Central contacts

Yesenia Calzada

424.946.5026YCalzada@mednet.ucla.edu

Locations

Yesenia Calzada

Recruiting

Los Angeles, California, United States, 90095

Contacts

Yesenia Calzada

424-946-5026YCalzada@mednet.ucla.edu

Principal Investigator:

Claudio Scafoglio, MD, PhD

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

Nov 10, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center on 2025-11-10.