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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Régional Metz-Thionville

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

with known allergy to gadolinium-based contrast agents (Gd-CAs)

with known severe renal impairment (GFR < 30 mL/min)

on dialysis

with urinary incontinence

Trial design

Design model

Single group

Treatments tested in this trial

  • biological samples collection

    Other intervention

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

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: excretion kinetics of gadolinium contrast agents in patientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Urinary excretion of gadolinium-based contrast agents (Gd-CAs)

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.

Time frame
at 2 hours and a half after Gd-CAs injection

Secondary outcomes

1

Renal function

Glomerular filtration rate (GFR: mL/min) estimated by the CKD-EPI method on the day of MRI.

Time frame
Day 0 (MRI)
2

Volume of beverages

Volume of beverages drunk (mL) after each micturition, declared by the patient since Gd-CAs injection, to the nearest 100 mL.

Time frame
at 2 hours and a half after Gd-CAs injection
3

Time to first spontaneous micturition

Duration (in minutes) between time of Gd-CAs injection and time of first spontaneous micturition.

Time frame
up to 2 hours and a half after Gd-CAs injection
4

Study refusal rate

Percentage (%) of study refusal

Time frame
Day 0 (MRI)

Other outcomes

Sponsors and contacts

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