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)

March 18, 2026 updated by: Fondazione del Piemonte per l'Oncologia
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketogenic Diet Before FDG PET/CT
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.
Behavioral: 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.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At completion of cohort-level primary analysis, up to 12 months
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.
At completion of cohort-level primary analysis, up to 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione del Piemonte per l'Oncologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002-FPO25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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