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Trial Title:
An Investigational Scan (Me-4FDG PET/CT) for the Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cancer
NCT ID:
NCT05558904
Condition:
Lung Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma of Lung
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside
Description:
Given IV
Arm group label:
Diagnostic (Me-4FDG PET/CT)
Other name:
a-methyl-4[18F]-4-deoxy-D-glucopyranoside
Other name:
Alpha-methyl-4-[F-18]-fluoro-4-deoxy-d-glucopyranoside
Other name:
Me-4(18F)DG
Other name:
Me-4FDG
Other name:
Me4FDG
Other name:
METHYL 4-DEOXY-4-FLUORO-.ALPHA.-D-GLUCOPYRANOSIDE. F-18
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo PET/CT
Arm group label:
Diagnostic (Me-4FDG PET/CT)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Other
Intervention name:
Laboratory Biomarker Analysis
Description:
Correlative studies
Arm group label:
Diagnostic (Me-4FDG PET/CT)
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET/CT
Arm group label:
Diagnostic (Me-4FDG PET/CT)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
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.
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Yesenia Calzada
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yesenia Calzada
Phone:
424-946-5026
Email:
YCalzada@mednet.ucla.edu
Investigator:
Last name:
Claudio Scafoglio, MD, PhD
Email:
Principal Investigator
Start date:
January 19, 2023
Completion date:
October 1, 2026
Lead sponsor:
Agency:
Jonsson Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
LUNGevity Foundation
Agency class:
Other
Collaborator:
Agency:
American Cancer Society, Inc.
Agency class:
Other
Source:
Jonsson Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05558904
