7-day low-carb, high-fat (ketogenic) diet to improve FDG PET/CT detection of lepidic lung adenocarcinoma
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
This trial will test whether a personalized 7-day ketogenic (low-carb, high-fat) diet before an FDG PET/CT can improve detection of lepidic-predominant lung adenocarcinoma in adults with a suspicious lung nodule or confirmed diagnosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione del Piemonte per l'Oncologia Academic / other |
| Locations | 1 site (Candiolo, Torino (TO)) |
| Trial ID | NCT07479095 on ClinicalTrials.gov |
What this trial studies
This prospective proof-of-concept interventional study will enroll about 30 adults with CT evidence of a lung nodule suspicious for lepidic-predominant adenocarcinoma or histologically confirmed disease. Participants receive an individualized ketogenic diet for seven days prior to FDG PET/CT, with dietary assessments and basic labs performed on the day of imaging. PET/CT images will be independently read by two board-certified nuclear medicine physicians and compared against histopathology as the reference standard. Study-level results will also be compared with literature-reported diagnostic performance and a matched retrospective institutional cohort.
Who should consider this trial
Good fit: Adults (≥18) with a CT nodule suspicious for lepidic-predominant adenocarcinoma or biopsy-confirmed LPA, a target nodule ≥10 mm, ECOG 0–2, and willingness and ability to follow a controlled ketogenic diet for seven days are ideal candidates.
Not a fit: Patients with contraindications to the ketogenic diet or prolonged imaging (for example, renal failure, type 1 diabetes, pancreatitis, severe dyslipidemia), those with actively progressing other malignancies, pregnant or breastfeeding people, or those unable to adhere to the diet are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could reduce false-negative PET/CT scans and improve staging and treatment planning for patients with lepidic-predominant lung adenocarcinoma.
How similar studies have performed: Preclinical and translational data suggest ketogenic diets can increase tumor FDG uptake, but clinical evidence in lepidic-predominant adenocarcinoma is limited, so this application is largely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Candiolo, Torino (TO)
- Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060 — Candiolo, Torino (TO), Italy (Recruiting)
Study contacts
- Study coordinator: Alessio Rizzo, MD
- Email: alessio.rizzo@ircc.it
- Phone: 0119933794
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.