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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
Sponsor:
Collaborators:
LUNGevity Foundation
American Cancer Society, Inc.
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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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.

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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Diagnostic (Me-4FDG PET/CT)
Patients receive Me-4FDG tracer IV and then undergo PET/CT over 15 minutes.
 Drug: Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside
Given IV
Other Names:
  • 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

Procedure: Computed Tomography
Undergo PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography

Other: Laboratory Biomarker Analysis
Correlative studies

Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Yesenia Calzada 424.946.5026 YCalzada@mednet.ucla.edu

Locations
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United States, California
Yesenia Calzada Recruiting
Los Angeles, California, United States, 90095
Contact: Yesenia Calzada    424-946-5026    YCalzada@mednet.ucla.edu   
Principal Investigator: Claudio Scafoglio, MD, PhD         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
LUNGevity Foundation
American Cancer Society, Inc.
Investigators
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Principal Investigator: Claudio Scafoglio, MD, PhD UCLA / Jonsson Comprehensive Cancer Center
More Information
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT05558904    
Other Study ID Numbers: 22-000027
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

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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
Additional relevant MeSH terms:
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Adenocarcinoma of Lung
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site