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NCT Number: NCT07479095

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 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060

Candiolo, Torino (TO), 10060, Italy

Location status: Recruiting

Location contact

Alessio Rizzo, MD

CONTACT

[email protected]

+390119933794

About this study

Lepidic-predominant lung adenocarcinoma is a subtype of non-small cell lung cancer characterized by relatively low glucose metabolism, which may reduce the sensitivity of standard 2-[18F]FDG PET/CT. Preclinical and translational evidence suggests that a ketogenic diet may enhance tumour FDG uptake in this setting. This prospective proof-of-concept interventional study will enroll approximately 30 adults with CT evidence of a pulmonary nodule suspicious for LPA or histologically confirmed LPA. After informed consent, participants will undergo an initial dietary assessment and receive an individualized ketogenic diet plan. The ketogenic diet will be followed for 7 days prior to FDG PET/CT. On the day of imaging, participants will undergo a second dietary evaluation, laboratory testing, urinalysis, and PET/CT. PET/CT images will be reviewed independently by two board-certified nuclear medicine physicians. Diagnostic performance will be assessed using visual and semiquantitative PET parameters, with histopathological diagnosis as the reference standard. Study-level results will also be compared with values reported in the literature and with a matched retrospective cohort from the same institution.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketogenic diet

Behavioral

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

Diagnostic Test

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.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Comparison of diagnostic performance with literature-reported values

    Time frame: At completion of cohort-level primary analysis, up to 12 months

    Comparison of study estimates of sensitivity, specificity, accuracy, positive predictive value, and negative predictive value with values reported in the literature using Z-test analysis

  2. Comparison of diagnostic performance with a matched retrospective institutional cohort

    Time frame: At completion of cohort-level primary analysis, up to 12 months.

    Comparison of sensitivity, specificity, accuracy, positive predictive value, and negative predictive value between the prospective ketogenic-diet cohort and a matched retrospective institutional cohort. Semiquantitative PET metrics, including SUVmax, will also be compared between cohorts.

Study contacts

Contact information is provided by the study sponsor or research team.

Alessio Rizzo, MD

CONTACT

[email protected]

0119933794 ext. +39

Annamaria Nuzzo, PhD

CONTACT

[email protected]

+390119933844

Sponsors and collaborators

Lead sponsor

Fondazione del Piemonte per l'Oncologia

Other

Registry information

Acronym: KETO-FDG Lung

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 18, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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