Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT05609318
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2022-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Imaging Intravenous Iron
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], 'ancestors': [{'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}, 'targetDuration': '6 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2022-11-01', 'studyFirstSubmitQcDate': '2022-11-01', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To establish the kinetics of iron uptake into the heart, liver, spleen, kidney, skeletal muscle and blood following a single intravenous iron infusion (Ferric carboxymaltose, Ferinject, 1000mg)', 'timeFrame': 'baseline, 3hr, 14 days and 42 days post intravenous iron infusion', 'description': 'Changes from baseline in multi-organ magnetic resonance relaxometries (delta R1/R2/R2\\* (seconds) for each participant.'}], 'secondaryOutcomes': [{'measure': 'Determine the effects of iron infusion (Ferric carboxymaltose, Ferinject, 1000mg) on serum iron indices and serum markers of tissue iron damage.', 'timeFrame': 'baseline, 3hr, 14 days and 42 days post intravenous iron infusion', 'description': 'Change from baseline in:\n\n1. Serum iron indices: iron (uM), ferritin (mg/L), transferrin saturation (%), non-transferrin bound iron (uM)\n2. Serum markers of tissue iron damage, including but not limited to lipid peroxidation markers malondialdehyde (MDA in mM) and 4-Hydroxynonenal (HNE in mM)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iron-deficiency']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to track where the iron goes in different tissues in the hours, days and weeks after an intravenous iron infusion. We will track iron in tissues using MRI relaxometry parameters R1/R2/R2\\* which are well established as accurate indicators of tissue iron content.', 'detailedDescription': 'This is a prospective, observational, study exploring the kinetics of tissue iron uptake following intravenous iron infusion (Ferinject), received as part of standard clinical care in a group of iron-deficient patients.\n\nParticipants will be recruited through the Iron Deficiency Management Service, part of the Oxford University Hospitals NHS Foundation Trust (OUHFT) . Participants will receive their intravenous iron infusion (Ferinject) as part of their standard clinical care by an NHS clinician. They will undergo all the study MRI scans and additional study procedures at the Oxford Centre for Clinical Magnetic Resonance Research (OCMR), which is based at the John Radcliffe Hospital and is part of the Division of Cardiovascular Medicine within the Radcliffe Department of Medicine at the University of Oxford.\n\nEach participant will undergo 4 MRI scans; baseline, 3hours, 14 days and 42 days post intravenous iron infusion. Blood samples will also be collected at those timepoints for assessment of relevant heamatological and iron parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants are patients who require intravenous iron as part of their standard clinical care. They will be recruited from referrals to the Iron Deficiency Management Service (IDMS), part of Oxford University Hospitals NHS Foundation Trust (OUHFT). This service receives referrals from multiple sources across Oxfordshire.\n\nPatient referrals will be screened by members of the NHS Clinical team at IDMS to identify potentially eligible participants.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Aged 18 years or above.\n* Anaemia (haemoglobin less than 120g/L for women and less than 130g/L for men) and/or confirmed iron deficiency (ferritin less than 100mcg/L and/or transferrin saturation less than 20%).\n* Scheduled to receive intravenous iron for correction of iron deficiency.\n\nExclusion Criteria:\n\n* Any MRI incompatible implants (e.g. cardiac, neuro, ocular implants, surgical clips, aneurysm clips, shrapnel/bullets)\n* Pregnant or lactating participant\n* Acute decompensated heart failure\n* Unstable clinical status\n* Any other medical conditions which would influence the reliability of the study results determined by the investigators.\n* Any other contraindication to MRI to be confirmed by the qualified MRI operator, e.g. tattoos containing traces of metal.'}, 'identificationModule': {'nctId': 'NCT05609318', 'briefTitle': 'Imaging Intravenous Iron', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Study of Tissue Iron Uptake in Iron-Deficient Patients Receiving Intravenous Iron Replacement Therapy: A Prospective Observational Study (STUDY)', 'orgStudyIdInfo': {'id': 'PID16038'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'iron-deficient', 'description': 'patients prescribed intravenous iron infusion for the treatment of iron deficiency as part of standard clinical care'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 9DU', 'city': 'Oxford', 'state': 'Oxfordshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Samira Lakhal-Littleton', 'role': 'CONTACT', 'email': 'samira.lakhal-littleton@dpag.ox.ac.uk', 'phone': '01865 221172'}, {'name': 'Vanessa Ferreira', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Akshay Shah', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Paolo Polzella', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michael Desborough', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stefan Piechnik', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Oxford Centre for Clinical Magnetic Resonance Research (OCMR)', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}