Evaluation of Gadoterate in Patients With Renal Dysfunction
NCT ID: NCT02382380
Last Updated: 2025-08-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
46 participants
INTERVENTIONAL
2014-11-05
2024-03-20
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Gadoterate
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).
Gadoterate
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 Gadoterate
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).
No Gadoterate
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).
Interventions
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Gadoterate
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 Gadoterate
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Guerbet
INDUSTRY
Loyola University
OTHER
Responsible Party
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Principal Investigators
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Ari Goldberg, MD
Role: PRINCIPAL_INVESTIGATOR
Loyola University
Locations
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Loyola University Medical Center
Maywood, Illinois, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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206338
Identifier Type: -
Identifier Source: org_study_id
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