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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketogenic diet, 2-[18F]FDG PET/CT.
- Who it may be relevant to
- Registry conditions: Lepidic-Predominant Lung Adenocarcinoma, Lung Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- 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.]
Secondary outcome measures (2)
- Comparison of diagnostic performance with literature-reported values [Time frame: 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Italy · 1 center
- Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060 — Candiolo
Identifiers
NCT: NCT07479095 · 002-FPO25