Imaging Intravenous Iron
ConditionIron-deficiency
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Oxford
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant is willing and able to give informed consent for participation in the study.
Aged 18 years or above.
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%).
Scheduled to receive intravenous iron for correction of iron deficiency.
Disqualifiers
Any MRI incompatible implants (e.g. cardiac, neuro, ocular implants, surgical clips, aneurysm clips, shrapnel/bullets)
Pregnant or lactating participant
Acute decompensated heart failure
Unstable clinical status
Trial population
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. Patient referrals will be screened by members of the NHS Clinical team at IDMS to identify potentially eligible participants.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
12 Participants
are grouped into 1 trial groupGroup A: iron-deficient
Trial outcomes
Primary outcomes
1
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)
Changes from baseline in multi-organ magnetic resonance relaxometries (delta R1/R2/R2\* (seconds) for each participant.
Time frame
baseline, 3hr, 14 days and 42 days post intravenous iron infusionSecondary outcomes
1
Determine the effects of iron infusion (Ferric carboxymaltose, Ferinject, 1000mg) on serum iron indices and serum markers of tissue iron damage.
Change from baseline in: 1. Serum iron indices: iron (uM), ferritin (mg/L), transferrin saturation (%), non-transferrin bound iron (uM) 2. Serum markers of tissue iron damage, including but not limited to lipid peroxidation markers malondialdehyde (MDA in mM) and 4-Hydroxynonenal (HNE in mM)
Time frame
baseline, 3hr, 14 days and 42 days post intravenous iron infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov