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

NCT06191731 | Recruiting

• 1 other identifier: 2023-02-CHRMT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Magnetic Resonance Imaging

Keywords

Contrast agents; Gadolinium; Recycling; MRI; Gadoteric acid

Outcome Measures

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.

  at 2 hours and a half after Gd-CAs injection

Secondary Outcomes (5)

• Renal function

  Day 0 (MRI)

• Volume of beverages

  at 2 hours and a half after Gd-CAs injection

• Time to first spontaneous micturition

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

• Study refusal rate

  Day 0 (MRI)

• Rate of premature study exit

  at 2 hours and a half after Gd-CAs injection

Study Arms (1)

excretion kinetics of gadolinium contrast agents in patients

EXPERIMENTAL

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

Interventions

biological samples collection OTHER

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

excretion kinetics of gadolinium contrast agents in patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead
• University of Lorraine: collaborator

Study Sites (1)

CHR Metz-Thionville/Hopital de Mercy

Metz, Grand Est, France

RECRUITING

Study Officials

• Rémi DUPRES, MD

  CHR Metz Thionville Hopital Mercy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arpiné EL NAR, PhD

CONTACT

0033387557766; projet-recherche-clinique@chr-metz-thionville.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-center cohort descriptive study

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: April 12, 2024
• Primary Completion: April 12, 2026
• Study Completion: April 12, 2026
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)