Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:48 AM
Study NCT ID:
NCT07452250
Status:
RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ferumoxytol-enhanced Magnetic Resonance Venography in Patients With Venous Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D052203', 'term': 'Ferrosoferric Oxide'}], 'ancestors': [{'id': 'D005290', 'term': 'Ferric Compounds'}, {'id': 'D058085', 'term': 'Iron Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005296', 'term': 'Ferrous Compounds'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-02-28', 'studyFirstSubmitQcDate': '2026-02-28', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Diagnostic Success Rate', 'timeFrame': 'Up to 2 days post-intervention', 'description': 'The overall diagnostic success rate is defined as the proportion of vascular segments with an average image quality score of ≥ 3 (evaluated on a 5-point Likert scale, where 1 = non-diagnostic/unusable and 5 = excellent). A segment is considered successfully diagnosed only if two independent, blinded radiologists reach a consensus that it is "diagnosable".'}], 'secondaryOutcomes': [{'measure': 'Signal-to-Noise Ratio (SNR) Assessed by Ferumoxytol-enhanced Magnetic Resonance Venography', 'timeFrame': 'Up to 2 days post-intervention', 'description': 'Signal intensity measurements will be performed using RadiAnt DICOM Viewer software. For each vascular segment, an elliptical region of interest (ROI) covering approximately two-thirds of the vascular lumen will be employed to minimize the effect of partial volume effects. SNR is calculated as the mean signal intensity of the vessel divided by the standard deviation (SD) of the vessel signal intensity. The vessel SD is used in place of background SD, as SNR calculated using background SD is inconsistent across regions of an accelerated sparse image.'}, {'measure': 'Contrast-to-Noise Ratio (CNR) Assessed by Ferumoxytol-enhanced Magnetic Resonance Venography', 'timeFrame': 'Up to 2 days post-intervention', 'description': 'Signal intensity measurements will be performed using RadiAnt DICOM Viewer software. For each vascular segment, an elliptical ROI covering approximately two-thirds of the vascular lumen will be employed to minimize partial volume effects. The reference signal and standard deviation (SD) of the adjacent muscle will be measured on the same slice. CNR is calculated as the difference between the mean signal intensity of the vessel and that of the adjacent muscle, divided by the square root of the sum of the squared SDs of the vessel and the adjacent muscle.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Venous Diseases']}, 'referencesModule': {'references': [{'pmid': '30919067', 'type': 'BACKGROUND', 'citation': 'Stoumpos S, Hennessy M, Vesey AT, Radjenovic A, Kasthuri R, Kingsmore DB, Mark PB, Roditi G. Ferumoxytol magnetic resonance angiography: a dose-finding study in patients with chronic kidney disease. Eur Radiol. 2019 Jul;29(7):3543-3552. doi: 10.1007/s00330-019-06137-4. Epub 2019 Mar 27.'}, {'pmid': '38713277', 'type': 'BACKGROUND', 'citation': 'Liu Y, Cao B, Wang X, Zhong J, Li Z, Peng R, Zhao D, Gu N, Yang Q. Ferumoxytol-enhanced MR venography for mapping lower-extremity venous networks and evaluating varicose veins in patients with diabetes. Eur Radiol. 2024 Nov;34(11):7197-7207. doi: 10.1007/s00330-024-10772-x. Epub 2024 May 7.'}, {'pmid': '34936018', 'type': 'BACKGROUND', 'citation': 'Shahrouki P, Khan SN, Yoshida T, Iskander PJ, Ghahremani S, Finn JP. High-resolution three-dimensional contrast-enhanced magnetic resonance venography in children: comparison of gadofosveset trisodium with ferumoxytol. Pediatr Radiol. 2022 Mar;52(3):501-512. doi: 10.1007/s00247-021-05225-2. Epub 2021 Dec 22.'}, {'pmid': '33778639', 'type': 'BACKGROUND', 'citation': 'Gallo CJR, Mammarappallil JG, Johnson DY, Chalian H, Ronald J, Bashir MR, Kim CY. Ferumoxytol-enhanced MR Venography of the Central Veins of the Thorax for the Evaluation of Stenosis and Occlusion in Patients with Renal Impairment. Radiol Cardiothorac Imaging. 2020 Nov 19;2(6):e200339. doi: 10.1148/ryct.2020200339. eCollection 2020 Dec.'}, {'pmid': '24130008', 'type': 'BACKGROUND', 'citation': 'Bashir MR, Mody R, Neville A, Javan R, Seaman D, Kim CY, Gupta RT, Jaffe TA. Retrospective assessment of the utility of an iron-based agent for contrast-enhanced magnetic resonance venography in patients with endstage renal diseases. J Magn Reson Imaging. 2014 Jul;40(1):113-8. doi: 10.1002/jmri.24330. Epub 2013 Oct 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this single-center, prospective, evaluator-blinded study is to establish and optimize the imaging protocol for ferumoxytol-enhanced magnetic resonance venography (Fe-MRV) in patients with venous system diseases.\n\nCurrent gadolinium-based contrast agents used in MRI have limitations, including short circulation half-lives and potential risks for patients with renal impairment. Ferumoxytol, a superparamagnetic iron oxide nanoparticle, offers a longer imaging window and no renal toxicity, making it a promising alternative for vascular imaging.\n\nThis study will enroll 50 adult patients with suspected or confirmed venous structural abnormalities or circulation disorders. To determine the minimum effective diagnostic dose, each participant will receive a total dose of 3.0 mg/kg, administered as four equal intravenous aliquots, with MRI performed after each aliquot (cumulative doses: 0.75, 1.50, 2.25, and 3.0 mg/kg). Independent, blinded radiologists will evaluate the image quality at each cumulative dose level to determine the lowest possible dose required to achieve successful clinical diagnosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>= 18 years.\n* Suspected or preliminarily diagnosed venous structural abnormalities (e.g., lower-extremity veins, central veins) or venous circulation disorders requiring Fe-MRV evaluation.\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* History of allergy/hypersensitivity to iron or dextran, or known allergy-prone constitution.\n* Currently receiving other oral or intravenous iron products.\n* Hemosiderosis or hemochromatosis.\n* Prior hypersensitivity reaction to intravenous iron products, or any condition associated with iron overload.\n* Unable to undergo MRI for psychological reasons (e.g., claustrophobia) or physical reasons (e.g., non-MRI-compatible metallic implants/foreign bodies).\n* End-stage disease or life expectancy \\< 1 year.\n* Pregnant women.\n* Any other condition judged by the investigator to make the participant unsuitable for the study.'}, 'identificationModule': {'nctId': 'NCT07452250', 'briefTitle': 'Ferumoxytol-enhanced Magnetic Resonance Venography in Patients With Venous Diseases', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}, 'officialTitle': 'A Single-center, Evaluator-blinded Clinical Study of Polysaccharide Superparamagnetic Iron Oxide Injection for Magnetic Resonance Venography in Patients With Venous System Diseases', 'orgStudyIdInfo': {'id': '2025-0616-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fe-MRV Dose Optimization Group', 'description': 'All enrolled participants will receive a total dose of 3.0 mg/kg of ferumoxytol injection. The contrast agent is administered intravenously in four equal consecutive aliquots. An MRI scan is performed after each aliquot to evaluate image quality at cumulative doses of 0.75, 1.50, 2.25, and 3.0 mg/kg.', 'interventionNames': ['Drug: Ferumoxytol injection']}], 'interventions': [{'name': 'Ferumoxytol injection', 'type': 'DRUG', 'description': 'Ferumoxytol is a superparamagnetic iron oxide nanoparticle contrast agent. It is administered intravenously at a total dose of 3.0 mg/kg, divided into four equal consecutive aliquots (0.75 mg/kg each).', 'armGroupLabels': ['Fe-MRV Dose Optimization Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guangxiang Si', 'role': 'CONTACT', 'email': 'guangxiang_si@163.com', 'phone': '+86-17320005863'}], 'facility': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Guangxiang Si', 'role': 'CONTACT', 'email': 'guangxiang_si@163.com', 'phone': '+86-17320005863'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Individual participant data (IPD) will not be shared to protect patient privacy and comply with the hospital's data security and management policies."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Min Zhou', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief Physician (Vascular Surgery)', 'investigatorFullName': 'Min Zhou', 'investigatorAffiliation': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}}}}