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

NCT ID: NCT06191731

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-12
• Study Completion Date: 2026-04-12

Brief 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.

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.

Conditions

Magnetic Resonance Imaging

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

biological samples collection

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lorraine

OTHER

Sponsor Role: collaborator

Centre Hospitalier Régional Metz-Thionville

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rémi DUPRES, MD

Role: PRINCIPAL_INVESTIGATOR

CHR Metz Thionville Hopital Mercy

Locations

CHR Metz-Thionville/Hopital de Mercy

Metz, Grand Est, France

Site Status: RECRUITING

Countries

France

Central Contacts

Arpiné EL NAR, PhD

Role: CONTACT

projet-recherche-clinique@chr-metz-thionville.fr

0033387557766

Facility Contacts

Arpiné EL NAR, PhD

Role: primary

projet-recherche-clinique@chr-metz-thionville.fr

0033387557766

Other Identifiers

2023-02-CHRMT

Identifier Type: -

Identifier Source: org_study_id