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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione del Piemonte per l'Oncologia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Not suitable for prolonged imaging procedures.

Renal failure.

Type 1 diabetes mellitus.

Pancreatitis.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Ketogenic Diet Before FDG PET/CTExperimental treatment 2 interventions

Trial outcomes

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.

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 outcomes

1

Comparison of diagnostic performance with literature-reported values

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

Time frame
At completion of cohort-level primary analysis, up to 12 months
2

Comparison of diagnostic performance with a matched retrospective institutional cohort

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.

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

Other outcomes

Sponsors and contacts

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