Lung Cancer Clinical Trial

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

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 new glucose tracer Me-4FDG 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.

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Full 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 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.

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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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT05558904

Recruitment Status:

Not yet recruiting

Sponsor:

Jonsson Comprehensive Cancer Center

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There is 1 Location for this study

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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles California, 90095, United States More Info
Claudio Scafoglio
Contact
310-825-9577
Claudio Scafoglio
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT05558904

Recruitment Status:

Not yet recruiting

Sponsor:


Jonsson Comprehensive Cancer Center

How clear is this clinincal trial information?

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