Imaging Intravenous Iron

Iron-deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05609318
• Other study ID #: PID16038
• Status: Recruiting
• Start date: October 29, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Iron-deficiency

Locations

Country	Name	City	State
United Kingdom	Oxford Centre for Clinical Magnetic Resonance Research (OCMR)	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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