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

NCT ID: NCT05558904

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-19

Study Completion Date

2027-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (Me-4FDG PET/CT)

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Given IV

Computed Tomography

Intervention Type PROCEDURE

Undergo PET/CT

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/CT

Interventions

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

Given IV

Intervention Type DRUG

Computed Tomography

Undergo PET/CT

Intervention Type PROCEDURE

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Positron Emission Tomography

Undergo PET/CT

Intervention Type PROCEDURE

Other Intervention Names

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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 CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized Tomography CT CT Scan tomography Medical Imaging, Positron Emission Tomography PET PET Scan Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role lead

LUNGevity Foundation

OTHER

Sponsor Role collaborator

American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claudio Scafoglio, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UCLA / Jonsson Comprehensive Cancer Center

Locations

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Yesenia Calzada

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Yesenia Calzada

Role: CONTACT

Phone: 424.946.5026

Email: [email protected]

Facility Contacts

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Yesenia Calzada

Role: primary

Other Identifiers

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NCI-2022-06770

Identifier Type: REGISTRY

Identifier Source: secondary_id

22-000027

Identifier Type: -

Identifier Source: org_study_id