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 | Recruiting DMC

• 1 other identifier: 002-FPO25
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lepidic-Predominant Lung Adenocarcinoma; Lung Adenocarcinoma

Keywords

2-[18F]FDG PET/CT; Ketogenic Diet; Lepidic Adenocarcinoma; Lung Nodule; Diagnostic Accuracy

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• 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.

Study Arms (1)

Ketogenic Diet Before FDG PET/CT

EXPERIMENTAL

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; Diagnostic Test: 2-[18F]FDG PET/CT

Interventions

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.

Ketogenic Diet Before FDG PET/CT

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.

Ketogenic Diet Before FDG PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione del Piemonte per l'Oncologia: lead

Study Sites (1)

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

Candiolo, Torino (TO), 10060, Italy

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Alessio Rizzo, MD

CONTACT

0119933794; alessio.rizzo@ircc.it

Annamaria Nuzzo, PhD

CONTACT

+390119933844; annamaria.nuzzo@ircc.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is a single-arm, open-label study. However, PET/CT images will be independently reviewed by two board-certified nuclear medicine physicians using blinded image assessment.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-arm, open-label study. However, PET/CT images will be independently reviewed by two board-certified nuclear medicine physicians using blinded image assessment.

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start: July 3, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)