Imaging intravenous iron in the body

Study of tissue iron uptake in iron-deficient patients receiving intravenous iron replacement therapy: a prospective observational study (STUDY)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN15770553

Enrollment

Registered

2022-12-09

Start date

2022-10-01

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaemia and/or confirmed iron deficiency Haematological Disorders Anaemia, unspecified

Interventions

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-

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 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	—

Measure

Time frame

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 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

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026