Imaging Intravenous Iron

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

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.

Study Overview

• Status: Recruiting
• Conditions: Iron-deficiency

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 12

Contacts and Locations

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • Recruiting
      • Oxford Centre for Clinical Magnetic Resonance Research (OCMR)
      • Contact: Samira Lakhal-Littleton; Phone Number: 01865 221172; Email: samira.lakhal-littleton@dpag.ox.ac.uk
      • Sub-Investigator: Vanessa Ferreira
      • Sub-Investigator: Akshay Shah
      • Sub-Investigator: Paolo Polzella
      • Sub-Investigator: Michael Desborough
      • Sub-Investigator: Stefan Piechnik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
iron-deficient; patients prescribed intravenous iron infusion for the treatment of iron deficiency as part of standard clinical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, 3hr, 14 days and 42 days post intravenous iron infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: 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)	baseline, 3hr, 14 days and 42 days post intravenous iron infusion

Collaborators and Investigators

• Sponsor: University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Iron Metabolism Disorders; Iron Deficiencies
• Other Study ID Numbers: PID16038

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No