Adverse Reactions to MR and CT-examinations (Enhanced and Unenhanced) - Full Text View

Purpose

Rationale:

Contrast agents are important tools for MR/CT- examinations, when it comes to diagnosing diseases. But despite their frequent use in Denmark, they are not free of serious and potentially fatal adverse reactions. Examples of this are contrast-induced nephropathy (CIN) and nephrogenic systemic fibrosis (NSF). Therefore, it is extremely important to clarify if these adverse reactions are actually directly related to the use of contrast agents or to MR/CT- examinations.

Objective:

To prospectively assess the incidence of adverse reactions of iodine-containing CT and gadolinium- based MR contrast agents in a prospective design. A control group examined without the use of contrast agent will be included, so that the study can illuminate reported adverse events related to contrast agents and CT/MR- examinations. This project will in the long term mean that, any significant and life-threatening delayed adverse reactions will be discovered earlier and hence it will be more likely to treat the patients in good time for these adverse reactions.

The following series of hypotheses will be investigated in this study:

Renal as well as non-renal adverse reactions occurring are related to the use of contrast agent in MR-/CT-examination.
CIN occurs in patients undergoing a MR-/CT-examination with contrast agent.

Methods:

Approvals are obtained from The Copenhagen County Committee on Biomedical Research Ethics and Danish Data Protection Agency. A total of 1600 patients will be included from Department of Radiology at Herlev Hospital, where all the MR- and CT examinations will be performed. Patients will be divided into four groups (a, b, c and d) with 400 patients in each group. Group a and c (case group) undergo respectively MR and CT examination with contrast agent While group b and d (control group) will undergo respectively MR and CT examination without the use of contrast agent. For each patient the following will be recorded: Risk factors, renal function (eGFR) before and 72 hours after MR/CT- examination as well as the incidence of immediate reactions (within 30 min.). Furthermore, patients have to answer a questionnaire 72 hours and 1 month after MR/CT- examination about the severity and frequency of adverse reactions to contrast media.

Condition
Renal Adverse Events - Contrast Induced Nephropathy (CIN) Non-renal Adverse Events


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Prospective Clinical Trial to Investigate Adverse Reactions to MR and CT-examinations (Enhanced and Unenhanced)

Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:

Renal and non-renal adverse events to enhanced and unenhanced CT and MRI [ Time Frame: before, 3 days and 1 month after enhanced or unenhanced CT and MRI ] [ Designated as safety issue: No ]


Enrollment:	1467
Study Start Date:	May 2010
Study Completion Date:	October 2013
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
Enhanced MR (case group) those with an exposure to gadolinium-based contrast agent
Unenhanced MR (control group) those without an exposure to gadolinium-based contrast agent
Unenhanced CT (control group) those without an exposure to iodine-containing contrast agent
Enhanced CT (case group) those with an exposure to iodine-containing contrast agent

Show Detailed Description

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The population will be selected from Herlev Hospital, Department of Radiology. Patients referred to an MR/CT-examination will be offered participation in this study.

Criteria

Inclusion Criteria:

Patients who are referred to a MR/CT-examination at Herlev Hospital, Department of Radiology
Age > 18 years

Exclusion Criteria:

Age < 18 years
Increased metabolism (hyperthyroidism)
Dementia
Pregnancy / lactation
Patients who have undergone MR/CT- examinations within the last month prior to the actual examination
New MR/CT-examination (enhanced and unenhanced) in the observation period (one month).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01132339

Locations


Denmark
Department of Diagnostic Radiology,Copenhagen University Hospital Herlev
Herlev, Denmark, 2730

Sponsors and Collaborators

Copenhagen University Hospital at Herlev

Investigators


Principal Investigator:	Manal Azzouz, MSc Pharmacy	Department of Diagnostic Radiology,Copenhagen University Hospital Herlev
Study Director:	Henrik S Thomsen	Department of Diagnostic Radiology,Copenhagen University Hospital Herlev

More Information

Publications:

Weinreb JC. Which study when? Is gadolinium-enhanced MR imaging safer than iodine-enhanced CT? Radiology. 2008 Oct;249(1):3-8. doi: 10.1148/radiol.2491080075.

Hunt CH, Hartman RP, Hesley GK. Frequency and severity of adverse effects of iodinated and gadolinium contrast materials: retrospective review of 456,930 doses. AJR Am J Roentgenol. 2009 Oct;193(4):1124-7. doi: 10.2214/AJR.09.2520.

Morcos SK. Review article: Acute serious and fatal reactions to contrast media: our current understanding. Br J Radiol. 2005 Aug;78(932):686-93. Review.

Remy-Jardin M, Dequiedt P, Ertzbischoff O, Tillie-Leblond I, Bruzzi J, Duhamel A, Remy J. Safety and effectiveness of gadolinium-enhanced multi-detector row spiral CT angiography of the chest: preliminary results in 37 patients with contraindications to iodinated contrast agents. Radiology. 2005 Jun;235(3):819-26. Epub 2005 Apr 21.

Cutroneo P, Polimeni G, Curcuruto R, Calapai G, Caputi AP. Adverse reactions to contrast media: an analysis from spontaneous reporting data. Pharmacol Res. 2007 Jul;56(1):35-41. Epub 2007 Mar 25.

Hosoya T, Yamaguchi K, Akutsu T, Mitsuhashi Y, Kondo S, Sugai Y, Adachi M. Delayed adverse reactions to iodinated contrast media and their risk factors. Radiat Med. 2000 Jan-Feb;18(1):39-45.

Ledneva E, Karie S, Launay-Vacher V, Janus N, Deray G. Renal safety of gadolinium-based contrast media in patients with chronic renal insufficiency. Radiology. 2009 Mar;250(3):618-28. doi: 10.1148/radiol.2503080253. Review.

Dillman JR, Ellis JH, Cohan RH, Strouse PJ, Jan SC. Frequency and severity of acute allergic-like reactions to gadolinium-containing i.v. contrast media in children and adults. AJR Am J Roentgenol. 2007 Dec;189(6):1533-8.

Grobner T. Gadolinium--a specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis? Nephrol Dial Transplant. 2006 Apr;21(4):1104-8. Epub 2006 Jan 23. Erratum in: Nephrol Dial Transplant. 2006 Jun;21(6):1745.

Marckmann P, Skov L, Rossen K, Dupont A, Damholt MB, Heaf JG, Thomsen HS. Nephrogenic systemic fibrosis: suspected causative role of gadodiamide used for contrast-enhanced magnetic resonance imaging. J Am Soc Nephrol. 2006 Sep;17(9):2359-62. Epub 2006 Aug 2.

Schild HH, Kuhl CK, Hübner-Steiner U, Böhm I, Speck U. Adverse events after unenhanced and monomeric and dimeric contrast-enhanced CT: a prospective randomized controlled trial. Radiology. 2006 Jul;240(1):56-64. Epub 2006 May 23.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Azzouz M, Rømsing J, Thomsen HS. Fluctuations in eGFR in relation to unenhanced and enhanced MRI and CT outpatients. Eur J Radiol. 2014 Jun;83(6):886-92. doi: 10.1016/j.ejrad.2014.02.014. Epub 2014 Feb 24.

Azzouz M, Rømsing J, Thomsen HS. Can a structured questionnaire identify patients with reduced renal function? Eur Radiol. 2014 Mar;24(3):780-4. doi: 10.1007/s00330-013-3065-x. Epub 2013 Nov 26.


Responsible Party:	Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:	NCT01132339 History of Changes
Other Study ID Numbers:	H-1-2010-011
Study First Received:	May 25, 2010
Last Updated:	January 25, 2014
Health Authority:	Denmark: Danish Dataprotection Agency

Keywords provided by Copenhagen University Hospital at Herlev:


Adverse reactions to Gadolinium-based contrast agents. Adverse reactions to Iodine-basedcontrast agents.

ClinicalTrials.gov processed this record on September 27, 2016