Clinical trial Recruiting at 1 site Interventional Ages 18 and up

7-day low-carb, high-fat (ketogenic) diet to improve FDG PET/CT detection of lepidic lung adenocarcinoma

Official title: 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

Run by Fondazione del Piemonte per l'Oncologia · NCT07479095 · Data updated 2026-11-12

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.

More Lung Adenocarcinoma trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment30 (estimated)
SponsorFondazione del Piemonte per l'Oncologia
Academic / other
Locations1 site (Candiolo, Torino (TO))
StatusRecruiting
StartedJuly 3, 2025
Main results expectedDecember 30, 2026
Study endsMarch 30, 2027
Registry record updatedMarch 20, 2026
Trial IDNCT07479095 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060
    Candiolo, Torino (TO), Italy
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.