Magnetic Resonance ImagingGADODURABLENCT06191731
Kinetics of Urinary Excretion of Gadolinium Contrast Agents Used in MRI Examinations
A study testing biological samples collection in people with Magnetic Resonance Imaging, run by Centre Hospitalier Régional Metz-Thionville at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Magnetic Resonance Imaging
- What is being tested?
- biological samples collection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 12 Apr 2024to 12 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- under hydric or hydrosodic restriction
- unable to urinate independently
- Protected persons (under guardianship, curatorship or safeguard of justice)
- Pregnant or breast-feeding women
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mélanie JUNKE contact
France2 sites, 2 recruiting
- Recruiting
CHR Metz-Thionville/Hopital de Mercy
Metz, Grand Est
Arpiné EL NAR, PhD, 0033387557766, projet-recherche-clinique@chr-metz-thionville.fr
Rémi DUPRES, MD
- Recruiting
CHR Metz-Thionville / Hopital Bel Air
Thionville
Mélanie JUNKE, projet-recherche-clinique@chr-metz-thionville.fr
Elisabeth PARIZEL, MD
About this study
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.
Read the 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
- Being tested
- biological samples collection
- Keywords
- Contrast agents, Gadolinium, Recycling, MRI, Gadoteric acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological samples collectionOther
Urine samples are collected before Gd-CAs injection, and between 0- and two-and-a-half-hour post-injection of Gd-CAs.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: biological samples collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 2 hours and a half after Gd-CAs injection
Secondary outcomes (5)
Renal function
Glomerular filtration rate (GFR: mL/min) estimated by the CKD-EPI method on the day of MRI.
Measured: 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.
Measured: 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.
Measured: up to 2 hours and a half after Gd-CAs injection
Study refusal rate
Percentage (%) of study refusal
Measured: Day 0 (MRI)
Rate of premature study exit
Percentage (%) of premature study exit
Measured: at 2 hours and a half after Gd-CAs injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start12 Apr 2024
- Primary completion12 Apr 2028 (estimated)
- Study completion12 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-center cohort descriptive study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lorraine
- Responsible party
- Sponsor
- Investigators
- Rémi DUPRES, MD, Principal investigator, CHR Metz Thionville Hopital Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191731
- Sponsor's protocol ID
- 2023-02-CHRMT
- Acronym
- GADODURABLE
- Status last verified
- Jun 2026
- First submitted
- 20 Dec 2023
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetics of Urinary Excretion of Gadolinium Contrast Agents Used in MRI Examinations
- ClinicalTrials.gov ID
- NCT06191731
- Acronym / sponsor ID
- GADODURABLE / 2023-02-CHRMT
- Conditions
- Magnetic Resonance Imaging
- Keywords
- Contrast agents, Gadolinium, Recycling, MRI, Gadoteric acid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Collaborators
- University of Lorraine
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 12 Apr 2028 (estimated)
- Study completion
- 12 Apr 2028 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-center cohort descriptive study
| Arm | Type | Receives |
|---|---|---|
| excretion kinetics of gadolinium contrast agents in patients | Experimental | Other: biological samples collectionurine samples are collected before Gd-CAs injection, and between 0- and two-and-a-half-hour post-injection of Gd-CAs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biological samples collectionUrine samples are collected before Gd-CAs injection, and between 0- and two-and-a-half-hour post-injection of Gd-CAs. | Other | excretion kinetics of gadolinium contrast agents in patients |
Primary outcome
Urinary excretion of gadolinium-based contrast agents (Gd-CAs)
Time frame: at 2 hours and a half after Gd-CAs injection
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.
5 secondary outcomes
Renal function
Time frame: Day 0 (MRI)
Volume of beverages
Time frame: at 2 hours and a half after Gd-CAs injection
Time to first spontaneous micturition
Time frame: up to 2 hours and a half after Gd-CAs injection
Study refusal rate
Time frame: Day 0 (MRI)
Rate of premature study exit
Time frame: at 2 hours and a half after Gd-CAs injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mélanie JUNKE contact
Rémi DUPRES, MD principal investigator
CHR Metz Thionville Hopital Mercy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biological samples collection in people with Magnetic Resonance Imaging, run by Centre Hospitalier Régional Metz-Thionville at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arpiné EL NAR, PhD (0033387557766, projet-recherche-clinique@chr-metz-thionville.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary excretion of gadolinium-based contrast agents (Gd-CAs) (time frame: at 2 hours and a half after Gd-CAs injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.