Bracco Diagnostics Inc.
Princeton, NJ 08543
by Nycomed GmbH - 78224 Singen (Germany)
Revised September 2007
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with:
- acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2), or
- acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any readministration (See WARNINGS).
Media Articles Related to Prohance Multipack (Gadoteridol)
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IVD clinical and regulatory quiz - participants receive discount on Clinical Affairs and Regulatory Approvals for Diagnostics conference registration
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Diagnostic clinical and regulatory professionals are now eligible to receive a discount to the 5th Annual Clinical Affairs and Regulatory Approvals for Diagnostics Conference, October 27-29, 2014...
New diagnostic test for ADHD tracks involuntary eye movements
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Published Studies Related to Prohance Multipack (Gadoteridol)
Magnetic resonance evaluation of brain metastases from systemic malignances with two doses of gadobutrol 1.0 m compared with gadoteridol: a multicenter, phase ii/iii study in patients with known or suspected brain metastases. [2011.07]
OBJECTIVES: To determine the efficacy and safety of 2 doses of gadobutrol 1.0 M (0.1 and 0.2 mmol/kg body weight [BW]), compared with gadoteridol 0.5 M (0.2 mmol/kg BW), in contrast-enhanced magnetic resonance imaging (CE-MRI) of brain metastases in patients with known or suspected brain metastases from systemic malignancies. The study also compared the usefulness of gadobutrol in treatment planning for stereotactic radiosurgery (SRS)... CONCLUSION: In this study, a single dose of gadobutrol was shown to be noninferior to a double dose of gadoteridol at detecting brain metastases, and could be effectively used for treatment planning in patients eligible for SRS. A dose of gadobutrol 0.1 mmol/kg BW is recommended as the clinical dose for the detection of brain metastases.
Magnetic resonance evaluation of brain metastases from systemic malignances with
two doses of gadobutrol 1.0 m compared with gadoteridol: a multicenter, phase
ii/iii study in patients with known or suspected brain metastases. 
planning for stereotactic radiosurgery (SRS)... CONCLUSION: In this study, a single dose of gadobutrol was shown to be
Risk for nephrogenic systemic fibrosis with gadoteridol (ProHance) in patients who are on long-term hemodialysis. [2008.05]
BACKGROUND AND OBJECTIVES: Recent studies strongly link nephrogenic systemic fibrosis to gadolinium administration for magnetic resonance imaging. In a recent advisory, the Food and Drug Administration stated that all gadolinium-containing chelates are potentially associated with nephrogenic systemic fibrosis; however, most reported cases are linked to gadodiamide (Omniscan) and gadopentetate dimeglumine (Magnevist). Given the severe consequences of nephrogenic systemic fibrosis, it is critical to define the risks associated with each gadolinium-containing chelate. The purpose of this study was to examine nephrogenic systemic fibrosis risk in a hemodialysis population exposed to gadoteridol (ProHance)... CONCLUSIONS: It is concluded that the risk for nephrogenic systemic fibrosis with gadoteridol in patients who are on long-term hemodialysis may be lower than with gadodiamide and gadopentetate dimeglumine.
Clinical Trials Related to Prohance Multipack (Gadoteridol)
SH L 562BB Phase II/III Dose Justification and Gadoteridol-Controlled Comparative Study [Recruiting]
This study is conducted to compare the contrast effect and safety of SH L562BB with ProHance,
which has already been approved as a pharmaceutical product of similar indication.
Safety and Efficacy of Gadobutrol 1.0 Molar (Gadovist®) in Patients for Central Nervous System (CNS) Imaging [Recruiting]
This study involves the use of Magnetic Resonance Imaging (MRI) contrast agents called
gadobutrol (Gadovist) Injection and ProHance Injection. The purpose of this study is to look
at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol
when used for taking MR images of the brain and spine. The results of the MRI with
gadobutrol Injection will be compared to the results of MR images taken without contrast and
with the results of the MR images taken with ProHance.
Evaluation of the Risk of NSF Following ProHance Injection in Patients With Chronic Kidney Disease [Recruiting]
The objective of this long term study is to prospectively compare the incidence of NSF in
two cohorts (Cohort 1- patients with moderate chronic kidney disease eGFR 30-59 and Cohort
2- patients with severe chronic kidney disease or kidney failure eGFR <30).
Regadenoson Blood Flow in Type 1 Diabetes (RABITĀ¹D) [Not yet recruiting]
Cardiovascular disease (CVD) remains the major cause of mortality and morbidity in both type
1 (T1D) and type 2 (T2D) diabetes patients; modifications of traditional CVD risk factors
have had a limited impact. This project called Regadenoson Blood flow in Type 1 Diabetes
(RABITD) and is proposed as a sub-study of the Coronary Artery Calcification in Type 1
Diabetes (CACTI) study, which has established a unique cohort of 656 T1D patients (age
20-55, minimal diabetes duration of 10 yrs) and 764 non-diabetic controls. This cohort is
being followed for progression of coronary artery calcification (CAC) measured using the
electron beam tomography (EBT) for development of clinical CVD. Participants have been well
characterized during the baseline examination (4/00-3/02) and two follow-up re-examinations
3 and 6 years later. The study has provided important insights into the risk factors and
possible prevention of premature CVD in T1D. We are proposing assess a subset of this
population to determine vasodilatory reserve as it relates to early coronary atherosclerosis
Hypothesis: that myocardial blood imaging (MBF) reserve can be measured in Type 1 DM using
regadenoson stress cardiac magnetic resonance and that significantly reduced MBF is a marker
of extensive artherosclerotic disease correlated to coronary arterial calcification, plaque
formation and impaired vasodilatory reserve.
1. Determine the relationship between myocardial perfusion index (previously determined),
regional CBF and invasively measured coronary flow reserve
2. Measure coronary blood flow using regadenoson stress CMR and determine the myocardial
blood flow reserve in type 1 DM subjects compared to non-diabetic controls.
3. Determine the relationship between CBF reserve in vascular distributions to the degree
of coronary arterial calcification.
4. Determine the severity of CBF blood flow reduction and the relationship to perfusion
reserve measured by invasive coronary Doppler flow-wire under regadenoson between in
type 1 DM subjects compared to non-diabetic controls.