Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT07127627
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-17
First Post:
2025-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characterization of Abdomino-pelvic Lesions by 18Fluorine- Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072078', 'term': 'Positron Emission Tomography Computed Tomography'}], 'ancestors': [{'id': 'D049268', 'term': 'Positron-Emission Tomography'}, {'id': 'D014055', 'term': 'Tomography, Emission-Computed'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D064847', 'term': 'Multimodal Imaging'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D011877', 'term': 'Radionuclide Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 79}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2025-08-09', 'studyFirstSubmitQcDate': '2025-08-14', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the performance of 18F FDG PET/CT', 'timeFrame': '3 years', 'description': 'identify and characterize abdominopelvic lesions, initial staging, follow up of treatment and detection of recurrence in the abdominopelvic region, including determining their malignant or benign nature, and to determine the extent of disease, Assess the spread of disease to lymph nodes, distant metastases, or other areas, to facilitate proper management.'}], 'secondaryOutcomes': [{'measure': 'Evaluate the diagnostic power of alternative technologies', 'timeFrame': '3 years', 'description': 'Evaluate the diagnostic power of alternative technologies like dual time point images, bladder evacuation and forced diuresis in characterizing abdominopelvic lesions.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['abdominopelvic lesions'], 'conditions': ['Abdominal Sepsis']}, 'referencesModule': {'references': [{'pmid': '34996595', 'type': 'BACKGROUND', 'citation': 'Bouchelouche K. PET/CT in Bladder Cancer: An Update. Semin Nucl Med. 2022 Jul;52(4):475-485. doi: 10.1053/j.semnuclmed.2021.12.004. Epub 2022 Jan 5.'}, {'pmid': '38199915', 'type': 'BACKGROUND', 'citation': 'Khandelwal Y, Singh Parihar A, Sistani G, Ramirez-Fort MK, Zukotynski K, Subramaniam RM. Role of PET/Computed Tomography in Gastric and Colorectal Malignancies. PET Clin. 2024 Apr;19(2):177-186. doi: 10.1016/j.cpet.2023.12.004. Epub 2024 Jan 9.'}, {'pmid': '34130088', 'type': 'BACKGROUND', 'citation': 'Wang J, Liu X. Medical image recognition and segmentation of pathological slices of gastric cancer based on Deeplab v3+ neural network. Comput Methods Programs Biomed. 2021 Aug;207:106210. doi: 10.1016/j.cmpb.2021.106210. Epub 2021 May 29.'}, {'pmid': '39069275', 'type': 'BACKGROUND', 'citation': 'Sartin SL, Shetty DR, Strange CD, Gayer G, Ahuja J, Agrawal R, Truong MT. Pitfalls in Positron Emission Tomography/Computed Tomography in the Thorax and Abdomen. Semin Ultrasound CT MR. 2024 Dec;45(6):488-495. doi: 10.1053/j.sult.2024.07.012. Epub 2024 Jul 26.'}, {'pmid': '33392014', 'type': 'BACKGROUND', 'citation': 'Cao Y, Zhou K, Diao W, Long X, Tian F, Su M, Jia Z. Age-related changes of standardized uptake values in the blood pool and liver: a decade-long retrospective study of the outcomes of 2,526 subjects. Quant Imaging Med Surg. 2021 Jan;11(1):95-106. doi: 10.21037/qims-20-35.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to identify and characterize lesions in the abdominopelvic region detected by 18fluorine- fluorodeoxyglucose (FDG) positron Emission Tomography combined Computed Tomography (PET/CT) scan, including determining their malignant or benign nature, and to determine the extent of disease to facilitate proper management', 'detailedDescription': 'positron Emission Tomography combined Computed Tomography is a hybrid imaging that provides both anatomical and functional data that helps to differentiate between benign and malignant diseases. \\[18F\\]FDG is taken up by both normal cells utilizing glucose like (kidneys, ureters and urinary bladder due to urinary excretion, Variable degrees of uptake can also seen in the liver, spleen, bone marrow, bowel, testes and uterus) .and also the tumor cells which usually have a high glucose demand. This uptake is mediated by the cell surface carrier molecules designated as glucose transporters (GLUT) and can be measured with the semi quantitative index called standardized uptake values (SUV) Cancer cells divide rapidly and have greater metabolic rates. Through the upregulation of glucose transport proteins on the cell membrane, cancer cells exhibit enhanced glucose uptake . Studies have demonstrated that SUV of 2.5 can differentiate malignant versus benign tissues , thus, Proper characterization of abdomino-pelvic lesions will lead to improve chances for successful management and treatment.\n\nMultiple studies have shown that Dual-time point (DTP) 18F-FDG PET/CT may provide more help in the differentiation of malignant lesions from benign ones.as Dual-Time-Point PET/CT involves two scans, one early and one delayed, allowing for the assessment of FDG uptake kinetics, malignant tumors tend to show increased FDG uptake over time, indicating higher glucose metabolism. But benign Lesions or those with inflammatory processes may show a decrease or no significant change in FDG uptake over time.\n\nFDG activity in urine interferes with tumor activity. Therefore, the value of FDG PET has only a limited role in detecting tumors in the bladder wall and urinary tract, Thus several methods have been investigated and tested to reduce urine FDG activity: catheterization, dual-phase imaging, early PET images, late PET images after voiding, oral hydration, and forced diuresis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients were suspected of having malignancy (new, recurrent or metastatic) based on pathology or conventional radiological studies and were referred to nuclear medicine unit for 18F-FDG-PET-CT scan', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria: All of the patients were suspected of having malignancy (new, recurrent or metastatic) based on pathology or conventional radiological studies and were referred to nuclear medicine unit for 18F-FDG-PET-CT scan\n\nExclusion Criteria:\n\n* patients underwent recent abdominal or pelvic surgery.\n* patients with blood glucose level ˃200 mg/dL\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT07127627', 'acronym': '18F-FDG PET/CT', 'briefTitle': 'Characterization of Abdomino-pelvic Lesions by 18Fluorine- Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Characterization of Abdomino-pelvic Lesions in Cancer Patients by 18F-FDG PET/CT', 'orgStudyIdInfo': {'id': 'characterization by PET/CT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PET/CT', 'type': 'DEVICE', 'description': 'positron emission tomography/computed tomography'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'salma A samy, ass. lecturer', 'role': 'CONTACT', 'email': 'salmasamy95@aun.edu.eg', 'phone': '01069720261'}, {'name': 'waleed A diab, ass. prof', 'role': 'CONTACT', 'email': 'Waleed.diab@aun.edu.eg', 'phone': '01004242213'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer of nuclear medicine', 'investigatorFullName': 'Salma A samy', 'investigatorAffiliation': 'Assiut University'}}}}