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NCT05558904 | Recruiting | Lung Adenocarcinoma

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

Jonsson Comprehensive Cancer Center

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.

Condition or disease

Lung Adenocarcinoma

Intervention/treatment

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

Computed Tomography

Laboratory Biomarker Analysis

Positron Emission Tomography

Phase

Phase 1

Phase 2

Detailed 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.}}

Study Type : Interventional
Estimated Enrollment : 60 participants
Masking : None (Open Label)
Primary Purpose : Diagnostic
Official Title : Positron-Emission Tomography Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cancer
Actual Study Start Date : January 19, 2023
Estimated Primary Completion Date : October 1, 2025
Estimated Study Completion Date : October 1, 2026
Arm Intervention/treatment

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

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

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

Procedure: Computed Tomography

Other: Laboratory Biomarker Analysis

Procedure: Positron Emission Tomography
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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
An Investigational Scan (Me-4FDG PET/CT) for the Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cancer

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

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Locations

Recruiting

United States, California

Yesenia Calzada

The Angels, California, United States, 90095