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Clinical Trials in France / NCT06191731
Recruiting Not applicable

Kinetics of Urinary Excretion of Gadolinium Contrast Agents Used in MRI Examinations

NCT06191731 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Régional Metz-Thionville
Phase
Not applicable
Started
2024-04-12
Last updated
2026-08-21

Condition(s) studied

Magnetic Resonance Imaging

Investigational drug(s) / intervention(s)

biological samples collection

biological samples collection: Urine samples are collected before Gd-CAs injection, and between 0- and two-and-a-half-hour post-injection of Gd-CAs.

Study summary

This is a single-center cohort study aimed to describe the urinary excretion kinetics of gadolinium contrast agents (Gd-CAs). Patients with a prescription for injected MRI are invited to participate in the study. If they agree, blood and urine samples are collected before Gd-CAs injection, and urine samples are collected between 0- and two-and-a-half-hours post-injection of Gd-CAs.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Patients: * over 18 years of age * with a prescription for MRI with gadolinium-based contrast agents (Gd-CAs) injection validated by a radiologist * affiliated with a health insurance plan * have signed an informed consent form Exclusion Criteria: * Patients: * with known allergy to gadolinium-based contrast agents (Gd-CAs) * with known severe renal impairment (GFR \< 30 mL/min) * on dialysis * with urinary incontinence * with an ongoing urinary tract infection * under hydric or hydrosodic restriction * unable to urinate independently * Protected persons (under guardianship, curatorship or safeguard of justice) * Pregnant or breast-feeding women

Primary outcome measure(s)

  • Urinary excretion of gadolinium-based contrast agents (Gd-CAs) — at 2 hours and a half after Gd-CAs injection
    Describe the kinetics of urinary excretion of GdCAs during the 2H30 following gadoline contrast injection in patients undergoing injected MRI at the Mercy Hospital Medical Imaging Department. The cumulative quantity of gadolinium-based contrast agents (Gd-CAs) (mg) mesured in urine during spontaneous micturition between 0 and 2H30 after injection of gadoline contrast medium and during micturition on demand at 2.30 h. The amount of Gd present in the urine (directly associated with the presence of Gd-CAs) is determined by inductively coupled plasma mass spectrometry (ICPMS). Urine concentrations are expressed in µg/L. Taking into account the volume of urine collected, the quantity of Gd is calculated and expressed in mg. This quantity is then expressed as a percentage of the quantity of injected-Gd-CAs.

Trial sites (2)

FacilityCityRegionStatus
CHR Metz-Thionville/Hopital de Mercy Metz Grand Est Recruiting
CHR Metz-Thionville / Hopital Bel Air Thionville France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06191731 on ClinicalTrials.gov ↗ ← All trials in France