Clinical trial NCT05558904: 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
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Lung Adenocarcinoma
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: LUNGevity Foundation
name: American Cancer Society, Inc.
First posted: 2022-09-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Sensitivity of Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside (Me-4FDG) positron-emission tomography (PET) scans
timeFrame: within one month of surgery or biopsy
measure: Specificity of Me-4FDG for lung cancer
timeFrame: within one week of experimental PET/CT scan
measure: Optimal combination of sensitivity and specificity
timeFrame: within one week of experimental PET/CT scan
measure: Incidence of adverse events of Me-4FDG
timeFrame: From baseline to one week after Me-4FDG administration
measure: Efficacy of Me-4FDG in diagnosing lung cancer
timeFrame: within one week of the experimental PET/CT scan
Secondary outcomes:
measure: Correlation of Me-4FDG positivity with histopathological features (tumor grade)
timeFrame: within one month of surgery or biopsy
measure: Correlation of Me-4FDG positivity with histopathological features (expression of SGLT2)
timeFrame: within two months of surgery or biopsy
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Yesenia Calzada
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Claudio Scafoglio, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: