Low-glucose/High-fat Intake Dietary Regimen as a Tool for Empowering Diagnostic Accuracy of 2-[18F]FDG PET/CT in Lepidic-predominant Growth Lung Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Diagnostic performance of 2-[18F]FDG PET/CT after a 7-day ketogenic diet
研究概览
简要总结
This study evaluates whether a 7-day ketogenic dietary regimen before 2-[18F]FDG PET/CT can improve the diagnostic accuracy of imaging in adults with suspected or histologically confirmed lepidic-predominant lung adenocarcinoma (LPA). LPA frequently shows low glucose metabolism and may yield false-negative FDG PET/CT results. Approximately 30 participants will undergo a tailored ketogenic diet for 7 days before PET/CT. Imaging results will be compared with histopathology and additionally assessed against literature-reported diagnostic performance and a matched retrospective institutional cohort.
详细描述
Lepidic-predominant lung adenocarcinoma is a subtype of non-small cell lung cancer characterized by relatively low glucose metabolism, which may reduce the sensitivity of standard 2-[18F]FDG PET/CT. Preclinical and translational evidence suggests that a ketogenic diet may enhance tumour FDG uptake in this setting. This prospective proof-of-concept interventional study will enroll approximately 30 adults with CT evidence of a pulmonary nodule suspicious for LPA or histologically confirmed LPA. After informed consent, participants will undergo an initial dietary assessment and receive an individualized ketogenic diet plan. The ketogenic diet will be followed for 7 days prior to FDG PET/CT. On the day of imaging, participants will undergo a second dietary evaluation, laboratory testing, urinalysis, and PET/CT. PET/CT images will be reviewed independently by two board-certified nuclear medicine physicians. Diagnostic performance will be assessed using visual and semiquantitative PET parameters, with histopathological diagnosis as the reference standard. Study-level results will also be compared with values reported in the literature and with a matched retrospective cohort from the same institution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
This is a single-arm, open-label study. However, PET/CT images will be independently reviewed by two board-certified nuclear medicine physicians using blinded image assessment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Age 18 years or older.
- •CT evidence of a lung nodule suspicious for LPA or lung biopsy positive for LPA.
- •Target nodule diameter at least 10 mm.
- •ECOG performance status 0 to
- •Willingness and ability to adhere to a controlled ketogenic diet for 7 days.
- •Ability to comply with study procedures and visit schedule.
排除标准
- •Not suitable for prolonged imaging procedures.
- •Renal failure.
- •Type 1 diabetes mellitus.
- •Pancreatitis.
- •Severe dyslipidemia.
- •Other malignancies that are progressing or required active treatment within the previous 3 years.
- •Serious or unstable medical, psychiatric, or substance use disorders that could interfere with study participation.
- •Pregnancy or breastfeeding.
- •Refusal to participate
研究组 & 干预措施
Ketogenic Diet Before FDG PET/CT
Participants will receive an individualized ketogenic diet for 7 days before undergoing 2-[18F]FDG PET/CT. The study includes an initial dietary visit, a second dietary evaluation on the day of imaging, laboratory and urine testing, and PET/CT image acquisition.
干预措施: Ketogenic diet (Behavioral)
Ketogenic Diet Before FDG PET/CT
Participants will receive an individualized ketogenic diet for 7 days before undergoing 2-[18F]FDG PET/CT. The study includes an initial dietary visit, a second dietary evaluation on the day of imaging, laboratory and urine testing, and PET/CT image acquisition.
干预措施: 2-[18F]FDG PET/CT (Diagnostic Test)
结局指标
主要结局
Diagnostic performance of 2-[18F]FDG PET/CT after a 7-day ketogenic diet
时间窗: At day 0 after completion of the 7-day ketogenic diet and FDG PET/CT; final diagnostic performance analysis will be performed after histopathologic reference data are available for the enrolled cohort, up to 12 months.
Sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of visual and semiquantitative 2-\[18F\]FDG PET/CT for identification of LPA after a 7-day ketogenic diet. Histopathological diagnosis will be used as the reference standard. Visual assessment will classify scans as positive when target nodule uptake is equal to or greater than mediastinal blood pool background; semiquantitative assessment will include SUVmax-based evaluation.
次要结局
- Comparison of diagnostic performance with literature-reported values(At completion of cohort-level primary analysis, up to 12 months)
- Comparison of diagnostic performance with a matched retrospective institutional cohort(At completion of cohort-level primary analysis, up to 12 months.)