Imaging Intravenous Iron

NCT05609318 | Unknown

• 1 other identifier: PID16038
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Iron-deficiency

Outcome Measures

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)

  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 Outcomes (1)

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

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

Study Arms (1)

iron-deficient

patients prescribed intravenous iron infusion for the treatment of iron deficiency as part of standard clinical care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Oxford Centre for Clinical Magnetic Resonance Research (OCMR)

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 8, 2022
• Study Start: October 29, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 8, 2024

Record last verified: 2023-11

Locations

GB (1)