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
Recruiting · NCT07479095 · Interventional (participants receive a specific treatment) · Lead sponsor: Fondazione del Piemonte per l'Oncologia
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060 - Candiolo, Torino (TO), Italy