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.
Fondazione del Piemonte per l'Oncologia
30 participants
Jul 3, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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 2.
- Willingness and ability to adhere to a controlled ketogenic diet for 7 days.
- Ability to comply with study procedures and visit schedule.
Exclusion Criteria9
- 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
Interventions
Tailored low-glucose/high-fat ketogenic dietary regimen administered for 7 consecutive days before 2-\[18F\]FDG PET/CT. Compliance will be assessed by clinical review, laboratory testing, and urinalysis on the day of PET/CT.
FDG PET/CT performed after completion of the 7-day ketogenic diet. Images will undergo visual and semiquantitative assessment, including comparison of target nodule uptake with mediastinal blood pool background and measurement of SUVmax.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07479095