Kinetics of Urinary Excretion of Gadolinium Contrast Agents Used in MRI Examinations (GADODURABLE)

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.

Study Overview

• Status: Recruiting
• Conditions: Magnetic Resonance Imaging
• Intervention / Treatment: Other: biological samples collection

Detailed Description

The contrast agents used in MRI to characterize certain lesions contain a chemical element from the rare earth family: Gadolinium (Gd). Gd, in its isolated form, is toxic in humans, but it can still be used in the form of complex molecules such as gadolinium contrast agents (Gd-CAs), which retain its contrast power while greatly minimizing its toxicity.

The MRI is performed rapidly after the injection of Gd-CAs, and these compounds are eliminated by the urinary route in the first urine following the examination. After elimination, and in view of their very high stability, these compounds follow the path of wastewater via sewage treatment plants. However, the processes currently used in these plants do not retain them, and they remain present in the purified water discharged into rivers.

Work carried out at the Laboratoire Interdisciplinaire des Environnements Continentaux (LIEC) at the University of Lorraine has demonstrated the bioaccumulation of these compounds in freshwater organisms. Gd-CAs then follow the classic pathway of continental waters. It should be noted that the quantity of Gd released as a result of MRI activities has been estimated on average at 1 injection per 1 g of Gd used.

In order to prevent future environmental disorders, recovery of all or part of the Gd-CAs immediately after MRI by urine collection is undoubtedly the most effective approach.

The aim of this project is to assess the feasibility of such an approach, and to propose a protocol applicable to MRI involving the injection of gadolinium contrast agents for urine collection.

This project is part of the "Rare Earths" theme of LabEx R21. It will examine the possibility of recycling gadolinium as an element or as Gd-CAs.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arpiné EL NAR, PhD; Phone Number: 0033387557766; Email: projet-recherche-clinique@chr-metz-thionville.fr

Study Locations

• France
  • Grand Est
    • Metz, Grand Est, France
      • Recruiting
      • CHR Metz-Thionville/Hopital de Mercy
      • Contact: Arpiné EL NAR, PhD; Phone Number: 0033387557766; Email: projet-recherche-clinique@chr-metz-thionville.fr
      • Principal Investigator: Rémi DUPRES, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: excretion kinetics of gadolinium contrast agents in patients; urine samples are collected before Gd-CAs injection, and between 0- and two-and-a-half-hour post-injection of Gd-CAs.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at 2 hours and a half after Gd-CAs injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal function	Glomerular filtration rate (GFR: mL/min) estimated by the CKD-EPI method on the day of MRI.	Day 0 (MRI)
Volume of beverages	Volume of beverages drunk (mL) after each micturition, declared by the patient since Gd-CAs injection, to the nearest 100 mL.	at 2 hours and a half after Gd-CAs injection
Time to first spontaneous micturition	Duration (in minutes) between time of Gd-CAs injection and time of first spontaneous micturition.	up to 2 hours and a half after Gd-CAs injection
Study refusal rate	Percentage (%) of study refusal	Day 0 (MRI)
Rate of premature study exit	Percentage (%) of premature study exit	at 2 hours and a half after Gd-CAs injection

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville
• Collaborators: University of Lorraine
• Investigators: Principal Investigator: Rémi DUPRES, MD, CHR Metz Thionville Hopital Mercy

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2024
• Primary Completion (Estimated): April 12, 2026
• Study Completion (Estimated): April 12, 2026

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: MRI; Gadolinium; Contrast agents; Recycling; Gadoteric acid
• Other Study ID Numbers: 2023-02-CHRMT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No