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

Lung Adenocarcinoma Clinical Trial

Official title:

Positron-Emission Tomography Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05558904
• Other study ID #: 22-000027
• Secondary ID: NCI-2022-06770
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 19, 2023
• Est. completion date: October 1, 2026

Study information

• Verified date: January 2024
• Source: Jonsson Comprehensive Cancer Center
• Contact: Yesenia Calzada
• Phone: 424.946.5026
• Email: YCalzada[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma of Lung
• Lung Adenocarcinoma

Intervention

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

Procedure:
• Computed Tomography
Undergo PET/CT

Other:
• Laboratory Biomarker Analysis
Correlative studies

Procedure:
• Positron Emission Tomography
Undergo PET/CT

Locations

Country	Name	City	State
United States	Yesenia Calzada	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	American Cancer Society, Inc., LUNGevity Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within one month of surgery or biopsy
Primary	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.	within one week of experimental PET/CT scan
Primary	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.	within one week of experimental PET/CT scan
Primary	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.	From baseline to one week after Me-4FDG administration
Primary	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.	within one week of the experimental PET/CT scan
Secondary	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.	within one month of surgery or biopsy
Secondary	Correlation of Me-4FDG positivity with histopathological features (expression of SGLT2)	Will be evaluated experimentally with validated specific antibodies.	within two months of surgery or biopsy