Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT04814758
Status:
UNKNOWN
Last Update Posted:
2021-03-24
First Post:
2021-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DWI in the Diagnosis of Histological Types of Nephroblastoma in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009396', 'term': 'Wilms Tumor'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 230}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2023-12-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-23', 'studyFirstSubmitDate': '2021-03-04', 'studyFirstSubmitQcDate': '2021-03-23', 'lastUpdatePostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the differences in ADC values according to the malignancy degree of nephroblastoma in children', 'timeFrame': 'Point 1. 15 ± 3 days Before the start of therapy - the starting point.'}, {'measure': 'To evaluate the differences in ADC values according to the malignancy degree of nephroblastoma in children', 'timeFrame': 'Point 2. after pre-operative chemotherapy up to 1 week'}], 'secondaryOutcomes': [{'measure': 'To evaluate the reproducibility and compatibility of the ADC values measurement;', 'timeFrame': 'Point 1. 15 ± 3 days Before the start of therapy - the starting point.'}, {'measure': 'To evaluate the reproducibility and compatibility of the ADC values measurement;', 'timeFrame': 'Point 2. after pre-operative chemotherapy up to 1 week'}, {'measure': 'To assess the sensitivity and specificity of the MRI DWI sequence (ADC values) in the diagnosis of the malignancy degrees of nephroblastomas in children;', 'timeFrame': 'Point 1. 15 ± 3 days Before the start of therapy - the starting point.'}, {'measure': 'To assess the sensitivity and specificity of the MRI DWI sequence (ADC values) in the diagnosis of the malignancy degrees of nephroblastomas in children;', 'timeFrame': 'Point 2. after pre-operative chemotherapy up to 1 week'}, {'measure': 'To estimate the differences in ADC values within the intermediate degree of nephroblastoma malignancy in children', 'timeFrame': 'Point 1. 15 ± 3 days Before the start of therapy - the starting point.'}, {'measure': 'To estimate the differences in ADC values within the intermediate degree of nephroblastoma malignancy in children', 'timeFrame': 'Point 2. after pre-operative chemotherapy up to 1 week'}, {'measure': 'To assess the ADC values change in depending according to the provided chemotherapy.', 'timeFrame': 'Point 1. 15 ± 3 days Before the start of therapy - the starting point.'}, {'measure': 'To assess the ADC values change in depending according to the provided chemotherapy.', 'timeFrame': 'Point 2. after pre-operative chemotherapy up to 1 week'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['paediatric', 'oncology', 'kidney', 'DWI', 'MRI', 'nephroblastoma', 'Wilms tumour', 'quantitative estimation'], 'conditions': ['Nephroblastoma (Wilms Tumour)']}, 'descriptionModule': {'briefSummary': 'Initially, or after preoperative chemotherapy, patients with a kidney tumor are examined on 3T MR scanner or 1.5T MR scanner. A standard MRI study of the abdomen with contrast enhancement is performed. DWI (diffusion weighted) images are included in the standard investigation package and consist of diffusion maps. Then, using Philips workstation (ISP 9.0, Philips, Netherlands), DWI mapping and ADC values collection (mm2/s) are performed. The placement of region of interest (ROI) is selected in the kidney mass in a solid and cystic area with a size up to 100 mm2.\n\nAfter the preoperative abdomen MRI, a surgical treatment is performed. Histological material is directed to the pathologist, who carried out the histological staging by the malignancy degree (low, intermediate, high). The data is entered into the database and the relationship between ADC values and histological degrees of malignancy of nephroblastoma is investigated', 'detailedDescription': 'Initially, or after preoperative chemotherapy, patients with a kidney tumor are examined on 3T MR scanner or 1.5T MR scanner, using 8-channel body coil. A standard MRI study of the abdomen with contrast enhancement is performed. DWI (diffusion weighted) images are included in the standard investigation package and consist of diffusion maps (DWI 3b) with 3 b-factors (50; 600; 800 or others, optional). Then, using Philips workstation (ISP 9.0, Philips, Netherlands), DWI mapping and ADC values collection (mm2/s) are performed. The placement of region of interest (ROI) is selected in the kidney mass in a solid and cystic area with a size up to 100 mm2. The values are entered in the table due to the stage of the chemotherapy.\n\nAfter the preoperative abdomen MRI, a surgical treatment is performed. Histological material is directed to the pathologist, who carried out the histological staging by the malignancy degree (low, intermediate, high). The data is entered into the database and the relationship between ADC values and histological degrees of malignancy of nephroblastoma is investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age under 18 y.o.;\n2. Renal mass with confirmed histology.\n\nExclusion Criteria:\n\n1. Absolute contraindications to magnetic resonance imaging (pacemaker, ferromagnetic implants, etc.);\n2. Refusal to sign the informed consent.'}, 'identificationModule': {'nctId': 'NCT04814758', 'briefTitle': 'DWI in the Diagnosis of Histological Types of Nephroblastoma in Children', 'organization': {'class': 'OTHER', 'fullName': 'Federal Research Institute of Pediatric Hematology, Oncology and Immunology'}, 'officialTitle': 'Diffusion-weighted Images as an Additional Method for Diagnosing Histological Types of Nephroblastoma in Children', 'orgStudyIdInfo': {'id': 'NCPHOI-2019-08'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MRI DWI sequence (ADC values)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Initially and after pre-operative chemotherapy To evaluate the differences in ADC values according to the malignancy degree of nephroblastoma in children'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Evelina f Nazarova', 'role': 'CONTACT', 'email': 'evelina.nazarova@fccho-moscow.ru', 'phone': '+79161133945'}], 'overallOfficials': [{'name': 'Galina f Tereshchenko, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chief radiology department at Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal Research Institute of Pediatric Hematology, Oncology and Immunology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}