An Investigational Scan (Me-4FDG PET/CT) for the Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cancer
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|ClinicalTrials.gov Identifier: NCT05558904|
Recruitment Status : Recruiting
First Posted : September 28, 2022
Last Update Posted : January 30, 2023
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|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 sodium-glucose cotransporter-2 inhibitors.(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|
|Actual Study Start Date :||January 19, 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 surgery 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 (Lung Imaging Reporting and Data System), 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- Diagnosis of diabetes
- Current treatment with SGLT2 inhibitors or metformin
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
|Contact: Yesenia Calzada||424.946.5026||YCalzada@mednet.ucla.edu|
|United States, California|
|Los Angeles, California, United States, 90095|
|Contact: Yesenia Calzada 424-946-5026 YCalzada@mednet.ucla.edu|
|Principal Investigator: Claudio Scafoglio, MD, PhD|
|Principal Investigator:||Claudio Scafoglio, MD, PhD||UCLA / Jonsson Comprehensive Cancer Center|
|Responsible Party:||Jonsson Comprehensive Cancer Center|
|Other Study ID Numbers:||
NCI-2022-06770 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
|First Posted:||September 28, 2022 Key Record Dates|
|Last Update Posted:||January 30, 2023|
|Last Verified:||January 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Adenocarcinoma of Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Neoplasms by Site