Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-28 @ 7:49 AM
Study NCT ID:
NCT06202235
Status:
RECRUITING
Last Update Posted:
2025-02-26
First Post:
2024-01-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multifrequency MRE in Evaluation of Chronic Kidney Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2024-01-01', 'studyFirstSubmitQcDate': '2024-01-01', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of MRE in Identifying Renal Fibrosis in CKD Patients', 'timeFrame': '12 months', 'description': 'To evaluate the ability of Magnetic Resonance Elastography (MRE) to identify and quantify the extent of renal fibrosis in patients with Chronic Kidney Disease as compared to healthy volunteers.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic kidney disease', 'kidney fibrosis', 'MR elastography'], 'conditions': ['Chronic Kidney Disease (CKD)']}, 'referencesModule': {'references': [{'pmid': '32367323', 'type': 'RESULT', 'citation': 'Han JH, Ahn JH, Kim JS. Magnetic resonance elastography for evaluation of renal parenchyma in chronic kidney disease: a pilot study. Radiol Med. 2020 Dec;125(12):1209-1215. doi: 10.1007/s11547-020-01210-1. Epub 2020 May 4.'}, {'pmid': '31287390', 'type': 'RESULT', 'citation': 'Grossmann M, Tzschatzsch H, Lang ST, Guo J, Bruns A, Durr M, Hoyer BF, Grittner U, Lerchbaumer M, Nguyen Trong M, Schultz M, Hamm B, Braun J, Sack I, Marticorena Garcia SR. US Time-Harmonic Elastography for the Early Detection of Glomerulonephritis. Radiology. 2019 Sep;292(3):676-684. doi: 10.1148/radiol.2019182574. Epub 2019 Jul 9.'}]}, 'descriptionModule': {'briefSummary': 'Chronic Kidney Disease (CKD) is a major public health issue, leading to high mortality and the necessity for renal replacement therapy. Kidney fibrosis, resulting from chronic damage to kidney tissue, significantly determines CKD outcomes. Kidney biopsy, the gold standard for assessing fibrosis, is invasive and limited in its ability to reflect the heterogeneous nature of fibrosis. Consequently, there is growing interest in noninvasive methods, particularly Magnetic Resonance Elastography (MRE). MRE, which evaluates tissue stiffness, has shown potential for assessing kidney fibrosis. This study aims to use multifrequency MRE to assess renal fibrosis, focusing particularly on the early stages of CKD, to enhance understanding of its progression and relationship to clinical outcomes.', 'detailedDescription': "Chronic Kidney Disease (CKD) is a significant public health concern, impacting approximately 10% of the global population. Annually, millions face mortality or require renal replacement therapy due to CKD progression. Kidney fibrosis, a result of chronic parenchymal damage from various glomerular and tubulointerstitial insults, is a primary determinant of outcomes. Accurately assessing the extent and severity of fibrosis is vital for diagnosis and treatment. However, Glomerular Filtration Rate (GFR) may not diminish despite the presence of renal fibrosis, often until extensive damage occurs, owing to the kidney's compensatory abilities. Additionally, GFR reductions may not solely indicate chronic damage or parenchymal fibrosis.\n\nGFR estimates using serum markers offer only rough approximations of kidney fibrosis and can be misleading. The gold standard for assessing kidney fibrosis is a kidney biopsy. However, biopsies are invasive, with potential complications and sampling errors, as they assess less than 1% of the kidney parenchyma. Given the heterogeneous and patchy nature of fibrosis within kidneys, the efficacy of biopsies is further questioned. Serial biopsies to track fibrosis progression are also impractical.\n\nThe need for noninvasive, accurate fibrosis assessment has led to research into various imaging techniques, including ultrasound and Magnetic Resonance Imaging (MRI). Among numerous MRI techniques explored for fibrosis assessment, Magnetic Resonance Elastography (MRE) appears promising. MRE, combining MRI with acoustic wave assessment, quantitatively determines tissue viscoelastic properties in response to external mechanical vibration. Initially developed for liver fibrosis assessment, kidney studies have shown that MRE-determined stiffness mildly negatively correlates with CKD stages and positively with fibrosis in renal allografts and diabetic kidneys. While kidney stiffness increases with fibrosis in renal allografts, it decreases with GFR in diabetic nephropathy. In CKD progression, marked by increased fibrosis and decreased GFR, these opposing effects on renal stiffness could limit MRE's applicability in CKD patients. We hypothesize that in early-stage CKD, when GFR is normal or slightly elevated, MRE could effectively determine renal fibrosis severity. To date, no study has specifically explored renal fibrosis and stiffness correlation in early-stage CKD.\n\nTherefore, this study aims to evaluate renal fibrosis using multifrequency 3D-MRE-derived stiffness as a surrogate marker. This involves detecting renal fibrosis prior to CKD changes, distinguishing renal fibrosis from CKD stages, and comparing renal stiffness with clinicopathological correlates in CKD patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with CKD stages 1-4 and healthy age-matched adults as controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CKD patients at stages 1-5 .\n* Ages 18-65, all sexes and genders.\n* Subjects who have undergone renal MRI.\n* Hospitalized for renal biopsy with histopathological examination; MRE sequence scanning completed within 3 days prior to renal biopsy.\n\nExclusion Criteria:\n\n* Patients with a cardiac pacemaker or other implanted electronic devices that are not MRI compatible\n* Patients who are pregnant or suspected to be pregnant\n* Patients with severe claustrophobia or anxiety\n* Patients who can not tolerate MRE\n* Patients who do not sign informed consent\n* Patients with acute exacerbation of chronic kidney disease, with creatinine levels rising more than 20% within one month or diagnosed with acute kidney injury (AKI).'}, 'identificationModule': {'nctId': 'NCT06202235', 'briefTitle': 'Multifrequency MRE in Evaluation of Chronic Kidney Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Shengjing Hospital'}, 'officialTitle': 'Multifrequency Renal MR Elastography in Evaluation of Chronic Kidney Diseases: Can Shear Stiffness Evaluate Renal Fibrosis in GFR-normal Patients?', 'orgStudyIdInfo': {'id': 'ShengjingH-CKD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CKD Patients', 'description': 'Participants with diagnosed Chronic Kidney Disease will undergo the same MRI protocol as the Healthy Volunteers, including T1-weighted, T2-weighted imaging, and Magnetic Resonance Elastography (MRE). In addition to the imaging, these participants will have their blood creatinine, cystatin C, and blood pressure measured within 3 days before and after the MRE. A renal biopsy will be performed as part of their clinical assessment to evaluate the extent of kidney fibrosis.', 'interventionNames': ['Diagnostic Test: Magnetic Resonance Imaging']}, {'label': 'Healthy Volunteers', 'description': 'Age-matched healthy individuals with no known kidney disease will be recruited. They will undergo the same MRI protocols as the CKD patient group, including T1-weighted, T2-weighted imaging, and MRE, to establish baseline viscoelasticity parameters for comparison with the CKD patients.', 'interventionNames': ['Diagnostic Test: Magnetic Resonance Imaging']}], 'interventions': [{'name': 'Magnetic Resonance Imaging', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['MR elastography'], 'description': 'Both CKD Patients and Healthy Volunteers will undergo Magnetic Resonance Elastography (MRE) to evaluate liver and renal viscoelasticity. For CKD patients, blood tests for creatinine and cystatin C, along with blood pressure measurements, will be taken within a three-day window surrounding the MRE test. Additionally, CKD patients will undergo a renal biopsy to assess the extent of fibrosis', 'armGroupLabels': ['CKD Patients', 'Healthy Volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110004', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Shi, MD', 'role': 'CONTACT', 'email': '18940259980@163.com', 'phone': '+8618940259980'}], 'facility': 'Shengjing Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'yu shi, MD', 'role': 'CONTACT', 'email': '18940259980@163.com', 'phone': '189 4025 9980'}], 'overallOfficials': [{'name': 'yu shi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shengjing Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shengjing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy director of department of radology', 'investigatorFullName': 'Yu Shi', 'investigatorAffiliation': 'Shengjing Hospital'}}}}