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Clinical Trials in Italy / NCT07479095
Recruiting Not 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

NCT07479095 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione del Piemonte per l'Oncologia
Phase
Not applicable
Started
2025-07-03
Last updated
2026-03-20

Condition(s) studied

Lepidic-Predominant Lung AdenocarcinomaLung Adenocarcinoma

Investigational drug(s) / intervention(s)

Ketogenic diet2-[18F]FDG PET/CT

Ketogenic diet: 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.

2-[18F]FDG 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Diagnostic performance of 2-[18F]FDG PET/CT after a 7-day ketogenic diet — 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.
    Sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of visual and semiquantitative 2-\[18F\]FDG PET/CT for identification of LPA after a 7-day ketogenic diet. Histopathological diagnosis will be used as the reference standard. Visual assessment will classify scans as positive when target nodule uptake is equal to or greater than mediastinal blood pool background; semiquantitative assessment will include SUVmax-based evaluation.

Trial sites (1)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07479095 on ClinicalTrials.gov ↗ ← All trials in Italy