An Investigational Scan (Me-4FDG PET/CT) for the Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05558904|
Recruitment Status : Not yet recruiting
First Posted : September 28, 2022
Last Update Posted : October 20, 2022
|Condition or disease||Intervention/treatment||Phase|
|Lung Adenocarcinoma||Drug: Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside Procedure: Computed Tomography Other: Laboratory Biomarker Analysis Procedure: Positron Emission Tomography||Phase 1 Phase 2|
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.
I. Evaluate the correlation of Me-4FDG positivity with histopathological features of the disease (tumor grade, expression of SGLT2).
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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Positron-Emission Tomography Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cancer|
|Estimated Study Start Date :||January 1, 2023|
|Estimated Primary Completion Date :||October 1, 2025|
|Estimated Study Completion Date :||October 1, 2026|
Experimental: Diagnostic (Me-4FDG PET/CT)
Patients receive Me-4FDG tracer IV and then undergo PET/CT over 15 minutes.
Procedure: Computed Tomography
Other: Laboratory Biomarker Analysis
Procedure: Positron Emission Tomography
- 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 surgurey or biopsy ]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.
- Specificity of Me-4FDG for lung cancer [ Time Frame: within one week of experimental PET/CT scan ]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 score 1-3.
- Optimal combination of sensitivity and specificity [ Time Frame: within one week of experimental PET/CT scan ]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.
- Incidence of adverse events of Me-4FDG [ Time Frame: From baseline to one week after Me-4FDG administration ]Will tabulate the number of adverse events (AEs) and the severity of adverse events (SAEs) for the overall population as well as within subjects.
- Efficacy of Me-4FDG in diagnosing lung cancer [ Time Frame: within one week of the experimental PET/CT scan ]Will be evaluated by measuring the percentage of test positivity in patients with a pathological diagnosis of lung cancer.
- Correlation of Me-4FDG positivity with histopathological features (tumor grade) [ Time Frame: within one month of surgery or biopsy ]Ordinal logistic regression will be used to assess the correlation between Me-4FDG uptake and tumor grade.
- Correlation of Me-4FDG positivity with histopathological features (expression of SGLT2) [ Time Frame: within two months of surgery or biopsy ]Will be evaluated experimentally with validated specific antibodies.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05558904
|United States, California|
|UCLA / Jonsson Comprehensive Cancer Center|
|Los Angeles, California, United States, 90095|
|Contact: Claudio Scafoglio 310-825-9577|
|Principal Investigator: Claudio Scafoglio|
|Principal Investigator:||Claudio Scafoglio||UCLA / Jonsson Comprehensive Cancer Center|