NCT07479095|RecruitingDMC
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
KETO-FDG Lung
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Sponsor study identifier
interventional
30
1 country
1
Study Start
July 3, 2025
Actual (reported)Primary Completion
December 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 3, 2025
Actual (reported)March 13, 2026
Actual (reported)March 18, 2026
Actual (reported)December 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Diagnostic performance of 2-[18F]FDG PET/CT after a 7-day ketogenic diet
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.
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.
Comparison of diagnostic performance with literature-reported values
At completion of cohort-level primary analysis, up to 12 months
Comparison of diagnostic performance with a matched retrospective institutional cohort
At completion of cohort-level primary analysis, up to 12 months.
Participants will receive an individualized ketogenic diet for 7 days before undergoing 2-\[18F\]FDG PET/CT. The study includes an initial dietary visit, a second dietary evaluation on the day of imaging, laboratory and urine testing, and PET/CT image acquisition.
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.
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.
Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060
Candiolo, Torino (TO), 10060, Italy
First Submitted
March 13, 2026
First Posted
March 18, 2026
Study Start
July 3, 2025
Actual (reported)Ketogenic Diet in Healthy Adults With Differing BMI
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Primary Completion
December 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 20, 2026
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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