Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT06737835
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-17
First Post:
2024-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metabolic Insights: the Impact of F-18 FDG PET/CT in Adult Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-12', 'studyFirstSubmitDate': '2024-12-01', 'studyFirstSubmitQcDate': '2024-12-12', 'lastUpdatePostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'primary', 'timeFrame': '3 years', 'description': 'Treatment Response Using Deauville Score for FDG Uptake Evaluation:\n\nEvaluate FDG uptake using the 5-point scale:\n\n1. No uptake above background\n2. Uptake ≤ mediastinum\n3. Uptake \\> mediastinum but ≤ liver\n4. Moderately increased compared to liver\n5. Markedly increased compared to liver X: New uptake, unlikely related to lymphoma'}], 'secondaryOutcomes': [{'measure': 'secondary', 'timeFrame': '3 years', 'description': 'Detect early relapse or residual disease using F-18 FDG PET/CT using SUVmax, maximum standardized uptake value(g/mL )'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['18 FDG PET CT', 'Lymphoma'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': '1. To assess staging accuracy of F-18 FDG PET/CT in lymphoma\n2. Determine the role of F-18 FDG PET/CT in monitoring treatment response and detecting relapse or residual disease in lymphoma\n3. To evaluate FDG uptake correlation with histopathological subtypes and immunophenotypes as a prognostic factor.', 'detailedDescription': "The incidence of lymphoma in Egypt has been increasing in recent years, with a noticeable rise in both Hodgkin's and non-Hodgkin's lymphoma cases. This increase is due to better healthcare, awareness, and diagnostic advancements. Risk factors include infections, lifestyle, genetics, and immune system issues.\n\nLymphoma is now the fourth most prevalent cancer among Egyptian adults, accounting for approximately 8.4% of all new cancer cases annually. As the burden of lymphoma grows, it becomes essential to develop effective strategies for its diagnosis and management.\n\nFlurodeoxyglucose F-18 (F-18 FDG) is a radiolabeled glucose analog that accumulates in metabolically active cells, such as lymphoma cells, making F-18 FDG positron emission tomography / computed tomography scan (PET/CT) highly sensitive for detecting malignant lesions. It plays a key role in staging lymphoma by assessing the extent of disease spread.\n\nAdditionally, F-18 FDG PET/CT is essential for assessing treatment response, detecting relapses early, and evaluating the prognosis of patients, offering prognostic value by evaluating residual disease and predicting recurrence. Its ability to monitor disease progression and detect recurrent lymphoma provides critical insights that guide therapeutic decisions and long-term outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a prospective study data collected from a single-center Clinical Oncology and Nuclear Medicine Department - Assuit University Hospital, which included 62 lymphoma cases who underwent F-18 FDG PET/CT for disease staging, treatment response assessment, or post-treatment monitoring.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: Patient must be older than 18 years.\n* Confirmed Diagnosis of Lymphoma: Patient must have a confirmed diagnosis of lymphoma based on histopathology and immunophenotyping.\n\nExclusion Criteria:\n\n* Patients with Known concomitant malignancy.\n* Pregnancy: Pregnant women due to the potential risks associated with radiation exposure from the PET/CT scan.\n* Severe Renal or Hepatic Impairment: Patients with significant renal or hepatic dysfunction that could affect FDG metabolism or excretion.\n* Uncontrolled Diabetes: Patients with uncontrolled diabetes (blood glucose \\>200 mg/dL), as it can affect FDG uptake and PET/CT results.'}, 'identificationModule': {'nctId': 'NCT06737835', 'briefTitle': 'Metabolic Insights: the Impact of F-18 FDG PET/CT in Adult Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Metabolic Insights: the Impact of F-18 FDG PET/CT in Adult Lymphoma', 'orgStudyIdInfo': {'id': 'PET/CT in adult lymphoma'}}, 'armsInterventionsModule': {'interventions': [{'name': '18 FDG', 'type': 'DEVICE', 'description': '18 flurodeoxy glucose PET/CT'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'contacts': [{'name': 'Aya A Al-sanoory, MSC', 'role': 'CONTACT', 'email': 'ayota17@gmail.com', 'phone': '00201063490867'}], 'facility': 'Nuclear medicine- Assiut University Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Aya A Ahmed Ali ALsanory, MSc', 'role': 'CONTACT', 'email': 'ayota17@gmail.com', 'phone': '00201063490867'}, {'name': 'Mohamed A Mekkawy, Prof', 'role': 'CONTACT', 'email': 'mmekkawy@aun.edu.eg', 'phone': '00201011580757'}], 'overallOfficials': [{'name': 'Esraa R Hassan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'South Egypt Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant lecturer', 'investigatorFullName': 'Aya Abdel-Baset Ahmed Ali Alsanory', 'investigatorAffiliation': 'Assiut University'}}}}