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

Magnetic Resonance Imaging Clinical Trial

— GADODURABLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06191731
• Other study ID #: 2023-02-CHRMT
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2024
• Est. completion date: April 12, 2025

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: Arpiné EL NAR, PhD
• Phone: 0033387557766
• Email: projet-recherche-clinique[@]chr-metz-thionville.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 12, 2025
• Est. primary completion date: April 12, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• with urinary catheterization or stoma

• Protected persons (under guardianship, curatorship or safeguard of justice)

• Pregnant or breast-feeding women

Related Conditions & MeSH terms

• Magnetic Resonance Imaging

Intervention

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.

Locations

Country	Name	City	State
France	CHR Metz-Thionville/Hopital de Mercy	Metz	Grand Est

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville	University of Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Renal function	Glomerular filtration rate (GFR: mL/min) estimated by the CKD-EPI method on the day of MRI.	Day 0 (MRI)
Secondary	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
Secondary	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
Secondary	Study refusal rate	Percentage (%) of study refusal	Day 0 (MRI)
Secondary	Rate of premature study exit	Percentage (%) of premature study exit	at 2 hours and a half after Gd-CAs injection