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

Официальное название

Positron-Emission Tomography Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cancer

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside
  Given IV
• Процедура Computed Tomography
  Undergo PET/CT
• Другое Laboratory Biomarker Analysis
  Correlative studies
• Процедура Positron Emission Tomography
  Undergo PET/CT

Первичные конечные точки

• Sensitivity of Alpha-methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside (Me-4FDG) positron-emission tomography (PET) scans [Срок оценки: within one month of surgery or biopsy]
• Specificity of Me-4FDG for lung cancer [Срок оценки: within one week of experimental PET/CT scan]
• Optimal combination of sensitivity and specificity [Срок оценки: within one week of experimental PET/CT scan]
• Incidence of adverse events of Me-4FDG [Срок оценки: From baseline to one week after Me-4FDG administration]
• Efficacy of Me-4FDG in diagnosing lung cancer [Срок оценки: within one week of the experimental PET/CT scan]

Вторичные конечные точки (2)

• Correlation of Me-4FDG positivity with histopathological features (tumor grade) [Срок оценки: within one month of surgery or biopsy]
• Correlation of Me-4FDG positivity with histopathological features (expression of SGLT2) [Срок оценки: within two months of surgery or biopsy]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Pregnancy
• Diagnosis of diabetes
• Current treatment with SGLT2 inhibitors or metformin

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Yesenia Calzada — Los Angeles

Идентификаторы

NCT: NCT05558904 · 22-000027 · NCI-2022-06770

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗