Gadolinium Retention in Human Bone Tissue in Pediatric Patients

NCT03337594 | Completed DMC FDA Drug

• 1 other identifier: Pro00048639
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare contrast agents, Dotarem or MultiHance. The study will test to see how much of these two contrast agents are deposited in the bones or tissues of pediatric patients. The patients receiving contrast will then be compared against pediatric patients who have not received any contrast prior to cardiac surgeries.

Conditions

Gadolinium; MultiHance; Dotarem; Magnetic Resonance Imaging; Gadolinium Retention

Keywords

Gadolinium; MultiHance; Dotarem; Contrast agents; Magnetic Resonance Imaging; Gadolinium retention; Pediatric; Bone

Outcome Measures

Primary Outcomes (1)

• To determine the gadolinium concentration present in bone tissue in pediatric patients following a standard of care MRI with MultiHance, Dotarem, or without any exposure to contrast.

  To determine the gadolinium concentration present in sternum and rib bone tissue in 2 groups of pediatric patients requiring cardiac surgery as part of their standard clinical treatment: (1) patients who had undergone the administration of a standard clinical dose of a linear GBCA (0.1 mmol/kg IV MultiHance), and (2) patients who had undergone the administration of a standard clinical dose of a macrocyclic GBCA (0.1 mmol/kg IV Dotarem). As a control, gadolinium concentration present in sternum bone tissue will also be determined in patients who had not been exposed to GBCA administration prior to surgery.

  July 2017 to October 2022

Secondary Outcomes (1)

• Asses the number of exposures to contrast agent as a potential confounder.

  July 2017 to October 2022

Study Arms (3)

Control

Pediatric patients who have not been exposed to gadolinium-based contrast agent administration and who require cardiac surgery as part of their standard clinical treatment.

Procedure: Surgery

Dotarem

Pediatric patients who have undergone routine contrast-enhanced MRI using only Dotarem contrast agent for clinical purposes and who require cardiac surgery as part of their standard clinical treatment.

Drug: Pre-operative MRI with Dotarem; Procedure: Surgery

MultiHance

Pediatric patients who have undergone routine contrast-enhanced MRI using only MultiHance contrast agent for clinical purposes and who require cardiac surgery as part of their standard clinical treatment.

Drug: Pre-operative MRI with MultiHance; Procedure: Surgery

Interventions

Pre-operative MRI with Dotarem DRUG

Dotarem® (gadoterate meglumine - Guerbet)

Also known as: gadoterate meglumine

Dotarem

Pre-operative MRI with MultiHance DRUG

MultiHance® (gadobenate dimeglumine - Bracco)

Also known as: gadobenate dimeglumine

MultiHance

Surgery PROCEDURE

Cardiac surgery

Control; Dotarem; MultiHance

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All subjects, newborn to 18 years, scheduled for a prospective clinically indicated, contrast-enhanced, cardiac MRI will potentially be eligible for inclusion into the study. Potential subjects will be identified via pediatric cardiology, pediatric cardiothoracic surgery, or clinical schedules and consultation with attending physicians according to satisfaction of the inclusion and exclusion criteria listed above.

You may qualify if:

• Female or male pediatric patient (patients aged newborn to 18 years old at the time of the MRI scan).
• Patients who require cardiac surgery for clinical purposes and meet one of the following three criteria:
• Patients who have undergone a routine contrast-enhanced MRI using MultiHance contrast agent only for clinical purposes.
• Patients who have undergone a routine contrast-enhanced MRI using Dotarem contrast agent only for clinical purposes.
• Patients who have not been exposed to gadolinium-based contrast agent administration

You may not qualify if:

• Patient with abnormal renal function (defined as eGFR MDRD\<30 ml/min/1.73m2).
• Patient previously exposed to any other type of MRI gadolinium based contrast agent either at MUSC or at an outside facility
• Pregnant or breast feeding female patient
• Patient with a contraindication to MRI (e.g., pacemaker, aneurysm clip, severe claustrophobia, infusion pumps, cochlear implants metallic or others according to standard practice at MUSC).

Sponsors & Collaborators

• Donna Roberts: lead
• National Institute of Standards and Technology: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (9)

• Hesselink JR, Press GA. MR contrast enhancement of intracranial lesions with Gd-DTPA. Radiol Clin North Am. 1988 Jul;26(4):873-87.

  PMID: 3289078 BACKGROUND

• Hesselink JR, Healy ME, Press GA, Brahme FJ. Benefits of Gd-DTPA for MR imaging of intracranial abnormalities. J Comput Assist Tomogr. 1988 Mar-Apr;12(2):266-74. doi: 10.1097/00004728-198803000-00015.

  PMID: 3351041 BACKGROUND

• Sherry AD, Caravan P, Lenkinski RE. Primer on gadolinium chemistry. J Magn Reson Imaging. 2009 Dec;30(6):1240-8. doi: 10.1002/jmri.21966.

  PMID: 19938036 BACKGROUND

• Bellin MF, Van Der Molen AJ. Extracellular gadolinium-based contrast media: an overview. Eur J Radiol. 2008 May;66(2):160-7. doi: 10.1016/j.ejrad.2008.01.023. Epub 2008 Mar 20.

  PMID: 18358659 BACKGROUND

• Hasebroock KM, Serkova NJ. Toxicity of MRI and CT contrast agents. Expert Opin Drug Metab Toxicol. 2009 Apr;5(4):403-16. doi: 10.1517/17425250902873796.

  PMID: 19368492 BACKGROUND

• Darrah TH, Prutsman-Pfeiffer JJ, Poreda RJ, Ellen Campbell M, Hauschka PV, Hannigan RE. Incorporation of excess gadolinium into human bone from medical contrast agents. Metallomics. 2009 Nov;1(6):479-88. doi: 10.1039/b905145g. Epub 2009 Sep 16.

  PMID: 21305156 BACKGROUND

• White GW, Gibby WA, Tweedle MF. Comparison of Gd(DTPA-BMA) (Omniscan) versus Gd(HP-DO3A) (ProHance) relative to gadolinium retention in human bone tissue by inductively coupled plasma mass spectroscopy. Invest Radiol. 2006 Mar;41(3):272-8. doi: 10.1097/01.rli.0000186569.32408.95.

  PMID: 16481910 BACKGROUND

• 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.

  PMID: 18344005 BACKGROUND

• Morcos SK. Extracellular gadolinium contrast agents: differences in stability. Eur J Radiol. 2008 May;66(2):175-9. doi: 10.1016/j.ejrad.2008.01.025. Epub 2008 Mar 14.

  PMID: 18343072 BACKGROUND

Related Links

• Link to contact Dr. Roberts
• NIST: National Institute of Standards and Technology

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bone and possibly skin tissue that are removed for routine care during the pediatric cardiothoracic surgery.

MeSH Terms

Interventions

gadoterate meglumine; gadobenic acid; Surgical Procedures, Operative

Study Officials

• Donna R Roberts, M.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Radiology and Radiological Science Department

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 9, 2017
• Study Start: October 1, 2017
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-07

Locations

US (1)