Lepidic-Predominant Lung AdenocarcinomaKETO-FDG LungNCT07479095
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
A study testing Ketogenic diet and 2-[18F]FDG PET/CT in people with Lepidic-Predominant Lung Adenocarcinoma and Lung Adenocarcinoma, run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lepidic-Predominant Lung Adenocarcinoma, Lung Adenocarcinoma
- What is being tested?
- Ketogenic diet and 2-[18F]FDG PET/CT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jul 2025to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Serious or unstable medical, psychiatric, or substance use disorders that could interfere with study participation.
- Pregnancy or breastfeeding.
- Refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060
Candiolo, Torino (TO), 10060
Alessio Rizzo, MD, +390119933794, alessio.rizzo@ircc.it
About this study
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.
Read the 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.
- Being tested
- Ketogenic diet, 2-[18F]FDG PET/CT
- Keywords
- 2-[18F]FDG PET/CT, Ketogenic Diet, Lepidic Adenocarcinoma, Lung Nodule, Diagnostic Accuracy
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietBehavioural
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/CTDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Ketogenic diet; Diagnostic Test: 2-[18F]FDG PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: At completion of cohort-level primary analysis, up to 12 months
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.
Measured: At completion of cohort-level primary analysis, up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start3 Jul 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lepidic-Predominant Lung AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479095
- Sponsor's protocol ID
- 002-FPO25
- Acronym
- KETO-FDG Lung
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07479095
- Acronym / sponsor ID
- KETO-FDG Lung / 002-FPO25
- Keywords
- 2-[18F]FDG PET/CT, Ketogenic Diet, Lepidic Adenocarcinoma, Lung Nodule, Diagnostic Accuracy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondazione del Piemonte per l'OncologiaUniversity, hospital or other
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ketogenic Diet Before FDG PET/CT | Experimental | Behavioral: Ketogenic diet, Diagnostic Test: 2-[18F]FDG PET/CTParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- Not suitable for prolonged imaging procedures.
- Renal failure.
- Type 1 diabetes mellitus.
- Pancreatitis.
- Severe dyslipidemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic dietTailored 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. | Behavioural | Ketogenic Diet Before FDG PET/CT |
| 2-[18F]FDG PET/CTFDG 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. | Diagnostic test | Ketogenic Diet Before FDG PET/CT |
Primary outcome
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.
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic diet and 2-[18F]FDG PET/CT in people with Lepidic-Predominant Lung Adenocarcinoma and Lung Adenocarcinoma, run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessio Rizzo, MD (0119933794 ext. +39, alessio.rizzo@ircc.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.