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

Jonsson Comprehensive Cancer Center

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Lung Adenocarcinoma

Treatments: Procedure: Positron Emission Tomography; Drug: Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside; Procedure: Computed Tomography; Other: Laboratory Biomarker Analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT05558904

NCI-2022-06770 (Registry Identifier)

22-000027

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Diagnostic (Me-4FDG PET/CT)

Experimental group

Description:

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

Treatment:

Other: Laboratory Biomarker Analysis

Procedure: Computed Tomography

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

Procedure: Positron Emission Tomography