Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT03879005
Status:
UNKNOWN
Last Update Posted:
2019-03-21
First Post:
2019-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Split Renal Function Using 99mTc-DTPA Versus 99mTc-DMSA in Kidney Patients of Wide Age Ranges.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-19', 'studyFirstSubmitDate': '2019-03-08', 'studyFirstSubmitQcDate': '2019-03-15', 'lastUpdatePostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Split renal function using 99mTc-DTPA versus 99mTc-DMSA in kidney patients of wide age ranges.', 'timeFrame': 'one year', 'description': 'To emphasize that split renal function calculated with Tc-99m DTPA is as reliable as Tc-99m DMSA'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['The Difference in Estimation of Split Renal Function Using the Two Radiopharmaceuticals:Tc-99m DTPA & Tc-99m DMSA in Kidney Patients']}, 'referencesModule': {'references': [{'pmid': '12601986', 'type': 'RESULT', 'citation': 'Ardela Diaz E, Miguel Martinez B, Gutierrez Duenas JM, Diez Pascual R, Garcia Arcal D, Dominguez Vallejo FJ. [Comparative study of differential renal function by DMSA and MAG-3 in congenital unilateral uropathies]. Cir Pediatr. 2002 Jul;15(3):118-21. Spanish.'}, {'pmid': '27623376', 'type': 'RESULT', 'citation': 'Cao X, Xu X, Grant FD, Treves ST. Estimation of Split Renal Function With 99mTc-DMSA SPECT: Comparison Between 3D Volumetric Assessment and 2D Coronal Projection Imaging. AJR Am J Roentgenol. 2016 Dec;207(6):1324-1328. doi: 10.2214/AJR.16.16307. Epub 2016 Sep 13.'}, {'pmid': '25538484', 'type': 'RESULT', 'citation': 'Celik T, Yalcin H, Gunay EC, Ozen A, Ozer C. Comparison of the Relative Renal Function Calculated with 99mTc-Diethylenetriaminepentaacetic Acid and 99mTc-Dimercaptosuccinic Acid in Children. World J Nucl Med. 2014 Sep;13(3):149-53. doi: 10.4103/1450-1147.144812.'}, {'pmid': '20363984', 'type': 'RESULT', 'citation': 'Lee WG, Kim JH, Kim JM, Shim KM, Kang SS, Chae HI, Choi SH. Renal uptakes of 99mTc-MAG3, 99mTc-DTPA, and 99mTc-DMSA in rabbits with unilateral ureteral obstruction. In Vivo. 2010 Mar-Apr;24(2):137-9.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate split renal function using Tc-99m DTPA versus Tc-99m DMSA.', 'detailedDescription': 'Split renal function (SPR) is a determination of the relative contribution of each of the two kidneys . It gives a useful information in several conditions such as evaluating unilateral renal disorders, assessing individual kidney function before and after intervention, and before live donor nephrectomy. Different radiopharmaceuticals such as technetium-99m dimercaptosuccinic acid (99mTc-DMSA), technetium-99m diethylenetriaminepentaaceticacid (99mTc-DTPA), technetium-99m mercaptoacetyltriglycine (99mTc-MAG3), Iodine 131 orthoiodohippurate and more recently technetium-99 m ethylenedicysteine (99mTc-EC) were used, However, 99mTc-DMSA as a static renal agent is considered the most reliable method to measure relative renal function and the most appropriate tracer for renal cortical imaging . In some papers, it is emphasized that relative renal function calculated with 99mTc-DTPA is as reliable as 99mTc-DMSA .\u202c The investigators design the study to evaluate the difference in estimation of split renal function using the available two radiopharmaceuticals: Tc-99m DTPA and Tc-99m DMSA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Kidney patients of wide age ranges.\n2. Patients with renal disorders who referred for DMSA and DTPA split renal function.\n3. Patients able to sleep in a fixed position for 20 minutes.\n\nExclusion Criteria:\n\n1. Children unable to sit calm without movement during imaging.\n2. Severely ill patients.\n3. Patients with allergy to one or more of material method.'}, 'identificationModule': {'nctId': 'NCT03879005', 'briefTitle': 'Split Renal Function Using 99mTc-DTPA Versus 99mTc-DMSA in Kidney Patients of Wide Age Ranges.', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Split Renal Function Using 99mTc-DTPA Versus 99mTc-DMSA in Kidney Patients of Wide Age Ranges', 'orgStudyIdInfo': {'id': 'SRF using DTPA Vs DMSA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Renal scintigraphy', 'description': '5 mci of 99mTc-DTPA or 99mTc-DMSA is injected once IV. Dose is adjusted according to age and weight.', 'interventionNames': ['Other: renal scintigraphy']}], 'interventions': [{'name': 'renal scintigraphy', 'type': 'OTHER', 'otherNames': ['99mTc-DTPA & 99mTc-DMSA renal scintigraphy'], 'description': "99mTc-DTPA Scintigraphy Five mci of 99mTc-DTPA will be injected by IV route together with diuretic. Dose will be adjusted according to the age and weight of the patients. A total of 20 min dynamic imaging followed by calculation of GFR and SRF according to the built-in processing protocol Gate's method.\n\n99mTc-DMSA scintigraphy Five mci of 99mTc- DMSA will be injected by IV route with adjustment according to age and weight. Static images will be acquired in the posterior, anterior, andposterior oblique projections for 60 s each.", 'armGroupLabels': ['Renal scintigraphy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marwa F Abd El Hay', 'role': 'CONTACT', 'email': 'f.marwa1992@gmail.com', 'phone': '0102291658'}, {'name': 'Waleed A Diab, MD', 'role': 'CONTACT', 'email': 'Drwaleedin2000@yahoo.com', 'phone': '01004242213'}], 'overallOfficials': [{'name': 'Mohamed AH Mekkawy, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Marwa Fathy', 'investigatorAffiliation': 'Assiut University'}}}}