RecruitingNot Applicable

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

Italy30 participantsStarted 2025-07-03

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Diagnostic performance of 2-[18F]FDG PET/CT after a 7-day ketogenic diet

Timeframe: 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.

Trial details

NCT IDNCT07479095

SponsorFondazione del Piemonte per l'Oncologia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-30

Contact for this trial

Alessio Rizzo, MD

0119933794 alessio.rizzo@ircc.it

View on ClinicalTrials.gov More Lepidic-Predominant Lung Adenocarcinoma trials