Evaluation of Gadoterate in Patients With Decreased Kidney Function

Renal Dysfunction Clinical Trial

Official title:

Evaluation of Gadoterate in Patients With Renal Dysfunction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02382380
• Other study ID #: 206338
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 2015
• Est. completion date: July 2020

Study information

• Verified date: June 2019
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The purpose of this study is to evaluate the safety and benefit of using a contrast material called Gadoterate in patients with decreased kidney function.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: July 2020
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Renal Dysfunction
• Renal Insufficiency

Intervention

Drug:
• 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).

Other:
• 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).

Locations

Country	Name	City	State
United States	Loyola University Medical Center	Maywood	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Loyola University	Guerbet

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2011 Oct 19. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. Erratum in: Clin J Am Soc Nephrol. 2009 Apr;4(4):866. — View Citation

Port M, Idée 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. — View Citation

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. — View Citation

Thomsen HS. Nephrogenic systemic fibrosis: A serious late adverse reaction to gadodiamide. Eur Radiol. 2006 Dec;16(12):2619-21. Epub 2006 Oct 24. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glomerular filtration rate (GFR)	Change in GFR from 0 to 6 months	6 months