Health Economic Evaluation of Primovist-enhanced Liver MRI
NCT ID: NCT00764621
Last Updated: 2014-11-04
Study Results
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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COMPLETED
PHASE4
360 participants
INTERVENTIONAL
2008-10-31
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Arm 1
Primovist MRI
Contrast-enhanced MRI with an i.v. application of Primovist in the approved dosage
Arm 2
Extracellular contrast media (ECCM) MRI
Contrast-enhanced MRI with an i.v. application of an approved extracellular contrast medium in the approved dosage
Arm 3
Contrast-enhanced CT
Contrast-enhanced 3 phase multidetector CT with an i.v. application of an approved iodinated contrast medium in the approved dosage
Interventions
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Primovist MRI
Contrast-enhanced MRI with an i.v. application of Primovist in the approved dosage
Extracellular contrast media (ECCM) MRI
Contrast-enhanced MRI with an i.v. application of an approved extracellular contrast medium in the approved dosage
Contrast-enhanced CT
Contrast-enhanced 3 phase multidetector CT with an i.v. application of an approved iodinated contrast medium in the approved dosage
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients who have received any contrast material within 24 hours before injection of study drug, or who are scheduled to receive any contrast material within 24 hours after injection
* Patients not eligible to contrast media (CM) injection according to product labeling
* Women who are pregnant, lactating or who are of childbearing potential and have not had a negative urine pregnancy test at baseline visit(s)
* Patients scheduled for liver-specific MRI other than Primovist-enhanced MRI, i.e. Multihance-, Teslascan- or SPIO-enhanced MRI
* Patients who are clinically unstable and whose clinical course is unpredictable (e.g. due to previous surgery, acute myocardial infarction)
* Patients with known anaphylactoid or anaphylactic reaction to any contrast media or hypersensitivity to any allergen including drugs
* Patients with a contraindication for MRI or CT.
* Patients with severe renal impairment (eGFR \< 30ml/min/1.73m2) or patients on dialysis
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Vienna, Vienna, Austria
Graz, , Austria
Vienna, , Austria
Karlsruhe, Baden-Wurttemberg, Germany
Tübingen, Baden-Wurttemberg, Germany
München, Bavaria, Germany
München, Bavaria, Germany
Frankfurt am Main, Hesse, Germany
Greifswald, Mecklenburg-Vorpommern, Germany
Dortmund, North Rhine-Westphalia, Germany
Dortmund, North Rhine-Westphalia, Germany
Dresden, Saxony, Germany
Magdeburg, Saxony-Anhalt, Germany
Berlin, State of Berlin, Germany
Candiolo, Torino, Italy
Ancona, , Italy
Bologna, , Italy
Brescia, , Italy
Chieti, , Italy
Napoli, , Italy
Amsterdam, , Netherlands
Leiden, , Netherlands
Utrecht, , Netherlands
Seoul, Korea, South Korea
Gyeunggi-do, South Korea, South Korea
Hwasun, , South Korea
Jeonbuk, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Barcelona, Barcelona, Spain
Santa Cruz de Tenerife, Canary Islands, Spain
Seville, Sevilla, Spain
Stockholm, , Sweden
Stockholm, , Sweden
Uppsala, , Sweden
Basel, Canton of Basel-City, Switzerland
Geneva, Canton of Geneva, Switzerland
Lucerne, Canton of Lucerne, Switzerland
Sankt Gallen, Canton of St. Gallen, Switzerland
Bern, , Switzerland
Bangkok, , Thailand
Songkhla, , Thailand
Countries
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References
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Zech CJ, Korpraphong P, Huppertz A, Denecke T, Kim MJ, Tanomkiat W, Jonas E, Ba-Ssalamah A; VALUE study group. Randomized multicentre trial of gadoxetic acid-enhanced MRI versus conventional MRI or CT in the staging of colorectal cancer liver metastases. Br J Surg. 2014 May;101(6):613-21. doi: 10.1002/bjs.9465. Epub 2014 Mar 20.
Related Links
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Click here and search for information of Bayer products for Europe
Other Identifiers
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312041
Identifier Type: OTHER
Identifier Source: secondary_id
2008-000583-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
91789
Identifier Type: -
Identifier Source: org_study_id
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