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Gadolinium Retention in Human Bone Tissue in Pediatric Patients

NCT ID: NCT03337594

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-01

Study Completion Date

2024-08-31

Brief Summary

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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.

Detailed Description

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When injected into the body, gadolinium contrast medium makes certain tissues, abnormalities or disease processes more clearly visible on a magnetic resonance imaging (MRI) scans and therefore gadolinium based contrast agents (GBCAs) are widely used in medical imaging. Recently, new evidence suggests that following GBCA administration, gadolinium can be deposited in body tissues even in the presence of normal renal function. Therefore, it is essential to ensure that significant accumulation of free Gd3+ is not occurring in the bones of children undergoing clinical contrasted MRI scans. This is particularly important for those pediatric patients who will undergo multiple repeated MRI exams throughout their lifetime and thereby be exposed to a large cumulative dose of gadolinium contrast. As the differences in stability between the various GBCAs may be a factor in gadolinium exposure, the primary objective of this study is to assess gadolinium deposition in the bones of pediatric patients in two patient groups: 1. patients who received IV administration of gadolinium contrast agent (Dotarem) and 2. patients who received IV administration of gadolinium contrast agent (MultiHance).

Once acquired the samples will be analyzed at an off-site facility, National Institute of Standards and Technology (NIST), using standardized equipment which has been certified for measuring gadolinium concentration in contrast agent samples. A signed agreement for the transfer of non-proprietary biological material between MUSC and NIST covers the transfer of the samples.

Conditions

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Gadolinium MultiHance Dotarem Magnetic Resonance Imaging Gadolinium Retention

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Surgery

Intervention Type PROCEDURE

Cardiac 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.

Pre-operative MRI with Dotarem

Intervention Type DRUG

Dotarem® (gadoterate meglumine - Guerbet)

Surgery

Intervention Type PROCEDURE

Cardiac 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.

Pre-operative MRI with MultiHance

Intervention Type DRUG

MultiHance® (gadobenate dimeglumine - Bracco)

Surgery

Intervention Type PROCEDURE

Cardiac surgery

Interventions

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Pre-operative MRI with Dotarem

Dotarem® (gadoterate meglumine - Guerbet)

Intervention Type DRUG

Pre-operative MRI with MultiHance

MultiHance® (gadobenate dimeglumine - Bracco)

Intervention Type DRUG

Surgery

Cardiac surgery

Intervention Type PROCEDURE

Other Intervention Names

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gadoterate meglumine gadobenate dimeglumine

Eligibility Criteria

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Inclusion Criteria

* 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:

1. Patients who have undergone a routine contrast-enhanced MRI using MultiHance contrast agent only for clinical purposes.
2. Patients who have undergone a routine contrast-enhanced MRI using Dotarem contrast agent only for clinical purposes.
3. Patients who have not been exposed to gadolinium-based contrast agent administration

Exclusion Criteria

* 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).
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Standards and Technology

UNKNOWN

Sponsor Role collaborator

Donna Roberts

OTHER

Sponsor Role lead

Responsible Party

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Donna Roberts

Professor, Radiology and Radiological Science Department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Donna R Roberts, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

References

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

Reference Type BACKGROUND
PMID: 3289078 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3351041 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19938036 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18358659 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19368492 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21305156 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16481910 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18344005 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18343072 (View on PubMed)

Related Links

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http://academicdepartments.musc.edu/facultydirectory/Roberts-Donna

Link to contact Dr. Roberts

https://www.nist.gov/

NIST: National Institute of Standards and Technology

Other Identifiers

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Pro00048639

Identifier Type: -

Identifier Source: org_study_id