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

• ClinicalTrials.gov Identifier: NCT05558904
• Recruitment Status: Recruiting
• First Posted: September 28, 2022
• Last Update Posted: January 30, 2023
• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: Lungevity Foundation; American Cancer Society, Inc.
• Information provided by (Responsible Party): Jonsson Comprehensive Cancer Center

Tracking Information

• First Submitted Date: September 12, 2022
• First Posted Date: September 28, 2022
• Last Update Posted Date: January 30, 2023
• Actual Study Start Date: January 19, 2023
• Estimated Primary Completion Date: October 1, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 27, 2023)

• 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.

Original Primary Outcome Measures (submitted: September 23, 2022)

• 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.

Current Secondary Outcome Measures (submitted: September 23, 2022)

• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Lung Adenocarcinoma

Intervention

• 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

Study Arms

Experimental: Diagnostic (Me-4FDG PET/CT)

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

Interventions:

• Drug: Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside
• Procedure: Computed Tomography
• Other: Laboratory Biomarker Analysis
• Procedure: Positron Emission Tomography

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 23, 2022): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 1, 2026
• Estimated Primary Completion Date: October 1, 2025 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05558904
• Other Study ID Numbers: 22-000027; NCI-2022-06770 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Jonsson Comprehensive Cancer Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Jonsson Comprehensive Cancer Center
• Original Study Sponsor: Same as current

Collaborators

• Lungevity Foundation
• American Cancer Society, Inc.

Investigators

• Principal Investigator: Claudio Scafoglio, MD, PhD; UCLA / Jonsson Comprehensive Cancer Center

• PRS Account: Jonsson Comprehensive Cancer Center
• Verification Date: January 2023