Imaging intravenous iron in the body

Not Applicable

• Conditions: Anaemia and/or confirmed iron deficiency; Haematological Disorders; Anaemia, unspecified

• Registration Number: ISRCTN15770553
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-09
• Last Update Posted: 29 July 2024
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

1. Participant is willing and able to give informed consent for participation in the study
2. Aged 18 years or above
3. Anaemia (haemoglobin less than 120 g/l for women and less than 130g/L for men) and/or confirmed iron deficiency (ferritin less than 100 mcg/l and/or transferrin saturation less than 20%)
4. Scheduled to receive intravenous iron for correction of iron deficiency

Exclusion Criteria

1. Any MRI incompatible implants (e.g. cardiac, neuro, ocular implants, surgical clips, aneurysm clips, shrapnel/bullets)
2. Pregnant or lactating participants
3. Acute decompensated heart failure
4. Unstable clinical status
5. Any other medical conditions which would influence the reliability of the study results determined by the investigators
6. Any other contraindication to MRI to be confirmed by the qualified MRI operator, e.g. tattoos containing traces of metal

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac structure and function (Cine MRI) and multi-organ magnetic resonance relaxometries (delta R1/R2/R2*) measured by magnetic resonance imaging (MRI) at baseline prior to infusion (day 1), 3 h post-infusion (day 1), ~2 weeks post-infusion, and ~6 weeks post-infusion

Secondary Outcome Measures

Name	Time	Method
1. Serum iron indices (iron, ferritin, transferrin saturation, non-transferrin bound iron) measured by standard clinical chemistry at baseline prior to infusion (day 1), 3 h post-infusion (day 1), ~2 weeks post-infusion, and ~6 weeks post-infusion<br>2. Serum markers of tissue iron damage, including but not limited to lipid peroxidation markers malondialdehyde (MDA) and 4- Hydroxynonenal (HNE) measured by ELISA at baseline prior to infusion (day 1), 3 h post-infusion (day 1), ~2 weeks post-infusion, and ~6 weeks post-infusion