Renal DysfunctionPhase 4NCT02382380

Evaluation of Gadoterate in Patients With Renal Dysfunction

A Phase 4 study testing Gadoterate and No Gadoterate in people with Renal Dysfunction, run by Loyola University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This study is for individuals with decreased kidney function whose doctor has ordered Magnetic Resonance Imaging (MRI). Because kidney function is decreased, these patients usually do not receive the intravenous contrast material that can improve the accuracy of the MRI findings. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Renal Dysfunction
What is being tested?: Gadoterate and No Gadoterate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteUnited States
Study dates: 5 Nov 2014to 20 Mar 2024
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Glomerular filtration rates (GFR) less than 30 ml/min but not on dialysis
Being sent for an MRI examination in the course of routine clinical evaluation of one of the following indications: suspected or known head/neck/brain mass, hepatic mass, renal mass, pancreatic mass, or prostate mass, as well as evaluation of carotid or abdominopelvic vasculature.

Who cannot join

Pregnant and lactating females
Planned initiation of chemotherapy or surgery within 72 hours of the MRI exam
Hemodynamic instability or acute coronary syndrome
History of nephrotoxic medication within 2 weeks of the exam
Less than 18 years old

Trial locations and contacts

1 site in 1 country.

United States1 site

Loyola University Medical Center
Maywood, Illinois, 60153

Other trials in United States

About this study

Read the detailed description

Gadolinium-based intravenous contrast agents are widely used for the enhancement of MRI findings. However, these agents have been implicated in varying degrees of nephrotoxicity and therefore are not usually used in patients with renal dysfunction. Gadoterate is a Gadolinium agent and previous studies have indicated that it is safe in patients with decreased kidney function. The purpose of this study is to evaluate the safety and efficacy of using Gadoterate in this patient population.

Participants who have been scheduled for an MRI will choose to either receive Gadoterate contrast as part of their MRI or not receive Gadoterate as part of their MRI.

Conditions: Renal Dysfunction
Being tested: Gadoterate, No Gadoterate
Keywords: Magnetic Resonance Imaging, Contrast Agent, Gadoterate
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GadoterateDrug
Also called Dotarem
Patients who choose to receive Gadoterate will receive an MRI exam with standard pre-contrast and Gadoterate-enhanced acquisitions (0.2 mL/kg). The MRI protocol utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography).
No GadoterateOther
Patients who choose not to receive Gadoterate will receive an MRI exam with no Gadolinium contrast. The MRI protocol utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography).

Study groups in NCT02382380
Study group	Role	What they receive
Gadoterate	Experimental	Patients who choose to receive Gadoterate will receive an MRI exam with standard pre-contrast and Gadoterate-enhanced acquisitions (0.2 mL/kg). The MRI protocol utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography). Receives: Drug: Gadoterate
No Gadoterate	Other	Patients who choose not to receive Gadoterate will receive an MRI exam with no Gadolinium contrast. MRI protocols utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography). Receives: Other: No Gadoterate

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Glomerular Filtration Rate (GFR)
Change in GFR from 0 to 72 hours
Measured: 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 201420 Mar 2024

First posted6 Mar 2015 (estimated)
Study start5 Nov 2014
Primary completion20 Mar 2024
Study completion20 Mar 2024

Why it stopped: The study was terminated by the Institutional Review Board

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Renal DysfunctionStudies 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 4
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02382380
Sponsor's protocol ID: 206338
Status last verified: Aug 2025
First submitted: 27 Feb 2015
Last updated: 13 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Thomsen HS. Nephrogenic systemic fibrosis: A serious late adverse reaction to gadodiamide. Eur Radiol. 2006 Dec;16(12):2619-21. doi: 10.1007/s00330-006-0495-8. Epub 2006 Oct 24. No abstract available.
PubMed 17061066
Sam AD 2nd, Morasch MD, Collins J, Song G, Chen R, Pereles FS. Safety of gadolinium contrast angiography in patients with chronic renal insufficiency. J Vasc Surg. 2003 Aug;38(2):313-8. doi: 10.1016/s0741-5214(03)00315-x.
PubMed 12891113
Perazella MA. Current status of gadolinium toxicity in patients with kidney disease. Clin J Am Soc Nephrol. 2009 Feb;4(2):461-9. doi: 10.2215/CJN.06011108.
PubMed 19201920
Janus N, Launay-Vacher V, Karie S, Clement O, Ledneva E, Frances C, Choukroun G, Deray G. Prevalence of nephrogenic systemic fibrosis in renal insufficiency patients: results of the FINEST study. Eur J Radiol. 2010 Feb;73(2):357-9. doi: 10.1016/j.ejrad.2008.11.021. Epub 2009 Jan 6.
PubMed 19128909
Port M, Idee JM, Medina C, Robic C, Sabatou M, Corot C. Efficiency, thermodynamic and kinetic stability of marketed gadolinium chelates and their possible clinical consequences: a critical review. Biometals. 2008 Aug;21(4):469-90. doi: 10.1007/s10534-008-9135-x. Epub 2008 Mar 15.
PubMed 18344005
Laurent S, Elst LV, Muller RN. Comparative study of the physicochemical properties of six clinical low molecular weight gadolinium contrast agents. Contrast Media Mol Imaging. 2006 May-Jun;1(3):128-37. doi: 10.1002/cmmi.100.
PubMed 17193689
Deray G, Rouviere O, Bacigalupo L, Maes B, Hannedouche T, Vrtovsnik F, Rigothier C, Billiouw JM, Campioni P, Ferreiros J, Devos D, Alison D, Glowacki F, Boffa JJ, Marti-Bonmati L. Safety of meglumine gadoterate (Gd-DOTA)-enhanced MRI compared to unenhanced MRI in patients with chronic kidney disease (RESCUE study). Eur Radiol. 2013 May;23(5):1250-9. doi: 10.1007/s00330-012-2705-x. Epub 2012 Dec 5.
PubMed 23212275
Maurer M, Heine O, Wolf M, Durmus T, Wagner M, Hamm B. Tolerability and diagnostic value of gadoteric acid in the general population and in patients with risk factors: results in more than 84,000 patients. Eur J Radiol. 2012 May;81(5):885-90. doi: 10.1016/j.ejrad.2011.04.022. Epub 2011 May 8.
PubMed 21555197
Herborn CU, Honold E, Wolf M, Kemper J, Kinner S, Adam G, Barkhausen J. Clinical safety and diagnostic value of the gadolinium chelate gadoterate meglumine (Gd-DOTA). Invest Radiol. 2007 Jan;42(1):58-62. doi: 10.1097/01.rli.0000248893.01067.e5.
PubMed 17213750
Broome DR, Girguis MS, Baron PW, Cottrell AC, Kjellin I, Kirk GA. Gadodiamide-associated nephrogenic systemic fibrosis: why radiologists should be concerned. AJR Am J Roentgenol. 2007 Feb;188(2):586-92. doi: 10.2214/ajr.06.1094.
PubMed 17242272
Lencioni R, de Baere T, Burrel M, Caridi JG, Lammer J, Malagari K, Martin RC, O'Grady E, Real MI, Vogl TJ, Watkinson A, Geschwind JF. Transcatheter treatment of hepatocellular carcinoma with Doxorubicin-loaded DC Bead (DEBDOX): technical recommendations. Cardiovasc Intervent Radiol. 2012 Oct;35(5):980-5. doi: 10.1007/s00270-011-0287-7. Epub 2011 Oct 19.
PubMed 22009576
Lima XT, Alora-Palli MB, Kimball AB, Kay J. Validation of a screening instrument for nephrogenic systemic fibrosis. Arthritis Care Res (Hoboken). 2013 Apr;65(4):637-42. doi: 10.1002/acr.21877.
PubMed 23097320

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Gadoterate in Patients With Renal Dysfunction
ClinicalTrials.gov ID: NCT02382380
Acronym / sponsor ID: 206338
Conditions: Renal Dysfunction
Keywords: Magnetic Resonance Imaging, Contrast Agent, Gadoterate
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated by the Institutional Review Board
Enrolment: 46 participants (actual)
Lead sponsor: Loyola UniversityUniversity, hospital or other
Collaborators: Guerbet
Study start: 5 Nov 2014 (actual)
Primary completion: 20 Mar 2024 (actual)
Study completion: 20 Mar 2024 (actual)
First posted: 6 Mar 2015 (estimated)
Results: Posted 13 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Participants who have been scheduled for an MRI will choose to either receive Gadoterate contrast as part of their MRI or not receive Gadoterate as part of their MRI.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Gadoterate	Experimental	Drug: GadoteratePatients who choose to receive Gadoterate will receive an MRI exam with standard pre-contrast and Gadoterate-enhanced acquisitions (0.2 mL/kg). The MRI protocol utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography).
No Gadoterate	Other	Other: No GadoteratePatients who choose not to receive Gadoterate will receive an MRI exam with no Gadolinium contrast. MRI protocols utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Glomerular filtration rates (GFR) less than 30 ml/min but not on dialysis
Being sent for an MRI examination in the course of routine clinical evaluation of one of the following indications: suspected or known head/neck/brain mass, hepatic mass, renal mass, pancreatic mass, or prostate mass, as well as evaluation of carotid or abdominopelvic vasculature.

Key exclusion criteria (5 listed)

Pregnant and lactating females
Planned initiation of chemotherapy or surgery within 72 hours of the MRI exam
Hemodynamic instability or acute coronary syndrome
History of nephrotoxic medication within 2 weeks of the exam
Less than 18 years old

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
GadoterateAlso: DotaremPatients who choose to receive Gadoterate will receive an MRI exam with standard pre-contrast and Gadoterate-enhanced acquisitions (0.2 mL/kg). The MRI protocol utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography).	Drug	Gadoterate
No GadoteratePatients who choose not to receive Gadoterate will receive an MRI exam with no Gadolinium contrast. The MRI protocol utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography).	Other	No Gadoterate

Primary outcome

Change in Glomerular Filtration Rate (GFR)
Time frame: 72 hours
Change in GFR from 0 to 72 hours

Results and safety

Results posted to the registry on 13 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gadoterate	33	31
No Gadoterate	13	10

Primary outcome: Change in Glomerular Filtration Rate (GFR)

Time frame: 72 hours. Median (Inter-Quartile Range). Unit: ml/minute

Measure	No Gadoterate n = 10	Gadoterate n = 31
Value	1.5 (1.0 to 5.0)	1.0 (-2.0 to 3.0)

Population analysed: The analysis population includes all participants with a baseline and 72-hour follow-up GFR assessment

Adverse events

Time frame: Adverse event data were collected for 3 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No Gadoterate	0 of 13 (0%)	0 of 13 (0%)	0 of 13
Gadoterate	5 of 33 (15.2%)	0 of 33 (0%)	5 of 33

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17061066Thomsen HS. Nephrogenic systemic fibrosis: A serious late adverse reaction to gadodiamide. Eur Radiol. 2006 Dec;16(12):2619-21. doi: 10.1007/s00330-006-0495-8. Epub 2006 Oct 24. No abstract available.
Background: PubMed 12891113Sam AD 2nd, Morasch MD, Collins J, Song G, Chen R, Pereles FS. Safety of gadolinium contrast angiography in patients with chronic renal insufficiency. J Vasc Surg. 2003 Aug;38(2):313-8. doi: 10.1016/s0741-5214(03)00315-x.
Background: PubMed 19201920Perazella MA. Current status of gadolinium toxicity in patients with kidney disease. Clin J Am Soc Nephrol. 2009 Feb;4(2):461-9. doi: 10.2215/CJN.06011108.
Background: PubMed 19128909Janus N, Launay-Vacher V, Karie S, Clement O, Ledneva E, Frances C, Choukroun G, Deray G. Prevalence of nephrogenic systemic fibrosis in renal insufficiency patients: results of the FINEST study. Eur J Radiol. 2010 Feb;73(2):357-9. doi: 10.1016/j.ejrad.2008.11.021. Epub 2009 Jan 6.
Background: PubMed 18344005Port M, Idee JM, Medina C, Robic C, Sabatou M, Corot C. Efficiency, thermodynamic and kinetic stability of marketed gadolinium chelates and their possible clinical consequences: a critical review. Biometals. 2008 Aug;21(4):469-90. doi: 10.1007/s10534-008-9135-x. Epub 2008 Mar 15.
Background: PubMed 17193689Laurent S, Elst LV, Muller RN. Comparative study of the physicochemical properties of six clinical low molecular weight gadolinium contrast agents. Contrast Media Mol Imaging. 2006 May-Jun;1(3):128-37. doi: 10.1002/cmmi.100.
Background: PubMed 23212275Deray G, Rouviere O, Bacigalupo L, Maes B, Hannedouche T, Vrtovsnik F, Rigothier C, Billiouw JM, Campioni P, Ferreiros J, Devos D, Alison D, Glowacki F, Boffa JJ, Marti-Bonmati L. Safety of meglumine gadoterate (Gd-DOTA)-enhanced MRI compared to unenhanced MRI in patients with chronic kidney disease (RESCUE study). Eur Radiol. 2013 May;23(5):1250-9. doi: 10.1007/s00330-012-2705-x. Epub 2012 Dec 5.
Background: PubMed 21555197Maurer M, Heine O, Wolf M, Durmus T, Wagner M, Hamm B. Tolerability and diagnostic value of gadoteric acid in the general population and in patients with risk factors: results in more than 84,000 patients. Eur J Radiol. 2012 May;81(5):885-90. doi: 10.1016/j.ejrad.2011.04.022. Epub 2011 May 8.
Background: PubMed 17213750Herborn CU, Honold E, Wolf M, Kemper J, Kinner S, Adam G, Barkhausen J. Clinical safety and diagnostic value of the gadolinium chelate gadoterate meglumine (Gd-DOTA). Invest Radiol. 2007 Jan;42(1):58-62. doi: 10.1097/01.rli.0000248893.01067.e5.
Background: PubMed 17242272Broome DR, Girguis MS, Baron PW, Cottrell AC, Kjellin I, Kirk GA. Gadodiamide-associated nephrogenic systemic fibrosis: why radiologists should be concerned. AJR Am J Roentgenol. 2007 Feb;188(2):586-92. doi: 10.2214/ajr.06.1094.
Background: PubMed 22009576Lencioni R, de Baere T, Burrel M, Caridi JG, Lammer J, Malagari K, Martin RC, O'Grady E, Real MI, Vogl TJ, Watkinson A, Geschwind JF. Transcatheter treatment of hepatocellular carcinoma with Doxorubicin-loaded DC Bead (DEBDOX): technical recommendations. Cardiovasc Intervent Radiol. 2012 Oct;35(5):980-5. doi: 10.1007/s00270-011-0287-7. Epub 2011 Oct 19.
Background: PubMed 23097320Lima XT, Alora-Palli MB, Kimball AB, Kay J. Validation of a screening instrument for nephrogenic systemic fibrosis. Arthritis Care Res (Hoboken). 2013 Apr;65(4):637-42. doi: 10.1002/acr.21877.
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. This study is not recruiting at the moment.

Ari Goldberg, MD principal investigator

Loyola University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Gadoterate and No Gadoterate in people with Renal Dysfunction, run by Loyola University at 1 site in United States.

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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glomerular Filtration Rate (GFR) (time frame: 72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02382380, which also lists 12 linked publications.

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 13 Aug 2025.