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NCT Number: NCT05609318

Imaging Intravenous Iron

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oxford Centre for Clinical Magnetic Resonance Research (OCMR)

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location status: Recruiting

Location contact

Akshay Shah

SUB_INVESTIGATOR

Michael Desborough

SUB_INVESTIGATOR

Paolo Polzella

SUB_INVESTIGATOR

Samira Lakhal-Littleton

CONTACT

[email protected]

01865 221172

Stefan Piechnik

SUB_INVESTIGATOR

Vanessa Ferreira

SUB_INVESTIGATOR

About this study

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.

Participants 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.

Each 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • Any other medical conditions which would influence the reliability of the study results determined by the investigators.
  • Any other contraindication to MRI to be confirmed by the qualified MRI operator, e.g. tattoos containing traces of metal.

Treatment and study plan

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)

    Time frame: baseline, 3hr, 14 days and 42 days post intravenous iron infusion

    Changes from baseline in multi-organ magnetic resonance relaxometries (delta R1/R2/R2* (seconds) for each participant.

Secondary outcomes

  1. Determine the effects of iron infusion (Ferric carboxymaltose, Ferinject, 1000mg) on serum iron indices and serum markers of tissue iron damage.

    Time frame: baseline, 3hr, 14 days and 42 days post intravenous iron infusion

    Change from baseline in:

    • Serum iron indices: iron (uM), ferritin (mg/L), transferrin saturation (%), non-transferrin bound iron (uM)
    • Serum markers of tissue iron damage, including but not limited to lipid peroxidation markers malondialdehyde (MDA in mM) and 4-Hydroxynonenal (HNE in mM)

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

Study of Tissue Iron Uptake in Iron-Deficient Patients Receiving Intravenous Iron Replacement Therapy: A Prospective Observational Study (STUDY)

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2022
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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