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

Primary Purpose

Lung Adenocarcinoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside
Computed Tomography
Laboratory Biomarker Analysis
Positron Emission Tomography
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yesenia CalzadaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (Me-4FDG PET/CT)

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
Correlation of Me-4FDG positivity with histopathological features (expression of SGLT2)
Will be evaluated experimentally with validated specific antibodies.

Full Information

First Posted
September 12, 2022
Last Updated
January 27, 2023
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
LUNGevity Foundation, American Cancer Society, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05558904
Brief Title
An Investigational Scan (Me-4FDG PET/CT) for the Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cancer
Official Title
Positron-Emission Tomography Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2023 (Actual)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
October 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
LUNGevity Foundation, American Cancer Society, Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Adenocarcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (Me-4FDG PET/CT)
Arm Type
Experimental
Arm Description
Patients receive Me-4FDG tracer IV and then undergo PET/CT over 15 minutes.
Intervention Type
Drug
Intervention Name(s)
Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside
Other Intervention Name(s)
a-methyl-4[18F]-4-deoxy-D-glucopyranoside, Alpha-methyl-4-[F-18]-fluoro-4-deoxy-d-glucopyranoside, Me-4(18F)DG, Me-4FDG, Me4FDG, METHYL 4-DEOXY-4-FLUORO-.ALPHA.-D-GLUCOPYRANOSIDE. F-18
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Intervention Description
Undergo PET/CT
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo PET/CT
Primary Outcome Measure Information:
Title
Sensitivity of Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside (Me-4FDG) positron-emission tomography (PET) scans
Description
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.
Time Frame
within one month of surgery or biopsy
Title
Specificity of Me-4FDG for lung cancer
Description
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.
Time Frame
within one week of experimental PET/CT scan
Title
Optimal combination of sensitivity and specificity
Description
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.
Time Frame
within one week of experimental PET/CT scan
Title
Incidence of adverse events of Me-4FDG
Description
Will tabulate the number of adverse events (AEs) and the severity of adverse events (SAEs) for the overall population as well as within subjects.
Time Frame
From baseline to one week after Me-4FDG administration
Title
Efficacy of Me-4FDG in diagnosing lung cancer
Description
Will be evaluated by measuring the percentage of test positivity in patients with a pathological diagnosis of lung cancer.
Time Frame
within one week of the experimental PET/CT scan
Secondary Outcome Measure Information:
Title
Correlation of Me-4FDG positivity with histopathological features (tumor grade)
Description
Ordinal logistic regression will be used to assess the correlation between Me-4FDG uptake and tumor grade.
Time Frame
within one month of surgery or biopsy
Title
Correlation of Me-4FDG positivity with histopathological features (expression of SGLT2)
Description
Will be evaluated experimentally with validated specific antibodies.
Time Frame
within two months of surgery or biopsy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yesenia Calzada
Phone
424.946.5026
Email
YCalzada@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Scafoglio, MD, PhD
Organizational Affiliation
UCLA / Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yesenia Calzada
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yesenia Calzada
Phone
424-946-5026
Email
YCalzada@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Claudio Scafoglio, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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