Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:15 AM
Study NCT ID:
NCT07479095
Status:
RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077192', 'term': 'Adenocarcinoma of Lung'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055423', 'term': 'Diet, Ketogenic'}], 'ancestors': [{'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': '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.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-13', 'studyFirstSubmitQcDate': '2026-03-13', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic performance of 2-[18F]FDG PET/CT after a 7-day ketogenic diet', 'timeFrame': '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.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Comparison of diagnostic performance with literature-reported values', 'timeFrame': 'At completion of cohort-level primary analysis, up to 12 months', 'description': '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'}, {'measure': 'Comparison of diagnostic performance with a matched retrospective institutional cohort', 'timeFrame': 'At completion of cohort-level primary analysis, up to 12 months.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['2-[18F]FDG PET/CT', 'Ketogenic Diet', 'Lepidic Adenocarcinoma', 'Lung Nodule', 'Diagnostic Accuracy'], 'conditions': ['Lepidic-Predominant Lung Adenocarcinoma', 'Lung Adenocarcinoma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent.\n* Age 18 years or older.\n* CT evidence of a lung nodule suspicious for LPA or lung biopsy positive for LPA.\n* Target nodule diameter at least 10 mm.\n* ECOG performance status 0 to 2.\n* Willingness and ability to adhere to a controlled ketogenic diet for 7 days.\n* Ability to comply with study procedures and visit schedule.\n\nExclusion Criteria:\n\n* Not suitable for prolonged imaging procedures.\n* Renal failure.\n* Type 1 diabetes mellitus.\n* Pancreatitis.\n* Severe dyslipidemia.\n* Other malignancies that are progressing or required active treatment within the previous 3 years.\n* Serious or unstable medical, psychiatric, or substance use disorders that could interfere with study participation.\n* Pregnancy or breastfeeding.\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT07479095', 'acronym': 'KETO-FDG Lung', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': "Fondazione del Piemonte per l'Oncologia"}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '002-FPO25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketogenic Diet Before FDG PET/CT', 'description': '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.', 'interventionNames': ['Behavioral: Ketogenic diet', 'Diagnostic Test: 2-[18F]FDG PET/CT']}], 'interventions': [{'name': 'Ketogenic diet', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Ketogenic Diet Before FDG PET/CT']}, {'name': '2-[18F]FDG PET/CT', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Ketogenic Diet Before FDG PET/CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10060', 'city': 'Candiolo', 'state': 'Torino (TO)', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessio Rizzo, MD', 'role': 'CONTACT', 'email': 'alessio.rizzo@ircc.it', 'phone': '+390119933794'}], 'facility': "Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060", 'geoPoint': {'lat': 44.95858, 'lon': 7.59812}}], 'centralContacts': [{'name': 'Alessio Rizzo, MD', 'role': 'CONTACT', 'email': 'alessio.rizzo@ircc.it', 'phone': '0119933794', 'phoneExt': '+39'}, {'name': 'Annamaria Nuzzo, PhD', 'role': 'CONTACT', 'email': 'annamaria.nuzzo@ircc.it', 'phone': '+390119933844'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione del Piemonte per l'Oncologia", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}