Trial Condition(s):

Colorectal Neoplasms, Neoplasm Metastasis

Health economic evaluation of Primovist-enhanced liver MRI

Bayer Identifier:

91789

ClinicalTrials.gov Identifier:

NCT00764621

EudraCT Number:

2008-000583-16

EU CT Number:

Not Available

Study Completed

Trial Purpose

Patients with a history of colorectal cancer and known or suspected liver metastases who are scheduled for contrast-enhanced tomographic imaging will be included in this study. After randomization to either Primovist-enhanced MRI, extracellular contrast media (ECCM)-enhanced MRI or contrast-enhanced (CE)-CT outcomes and resource needs of the diagnostic work-up and treatment will be evaluated for each of the three imaging modalities. Main objectives of the study are to assess the proportion of patients for whom further imaging is required to come to a therapy decision and to evaluate the proportion of patients with intraoperatively modified surgical plans after Primovist-enhanced MRI as compared to ECCM-enhanced MRI and CE-CT.

Inclusion Criteria
- Patients with known or suspected metachronous liver metastases secondary to colorectal cancer who are scheduled for further contrast-enhanced tomographic imaging
Exclusion Criteria
- Patients (men or women) under 18 years of age
 - 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

Trial Summary

Enrollment Goal
360
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Eovist/Primovist (Gadoxetate disodium, BAY86-4873)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
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Klinikum Großhadern der Ludwig-Maximilians-Universität

München, Germany, 81377

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Universitätsklinikum Otto-von Guericke - Magdeburg

Magdeburg, Germany, 39112

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Klinikum der Eberhard-Karls-Universität Tübingen

Tübingen, Germany, 72076

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AUSL Chieti - Abruzzo

Chieti, Italy, 66100

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A.O.U. Policlinico S.Orsola-Malpighi

Bologna, Italy, 40138

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Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

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University Medical Center Utrecht

UTRECHT, Netherlands, 3584 CX

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Nederlands Kanker Instituut

Amsterdam, Netherlands, 1066CX

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Leids Universitair Medisch Centrum

Leiden, Netherlands, 2333 ZA

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Danderyds sjukhus

Stockholm, Sweden, 182 88

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Akademiska Sjukhuset

Uppsala, Sweden, 75185

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Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Wien, Austria, 1090

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Krankenanstalt der Stadt Wien - Rudolfstiftung

Wien, Austria, 1030

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Medizinische Universität Graz

Graz, Austria, 8036

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Universitätsklinikum Charite zu Berlin

Berlin, Germany, 10117

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Klinikum rechts der Isar

München, Germany, 81675

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Städtisches Klinikum Karlsruhe gGmbH

Karlsruhe, Germany, 76133

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Klinikum der Johann Wolfgang Goethe Universität

Frankfurt, Germany, 60596

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Medizinisches Versorgungszentrum Prof. Dr. D. Uhlenbrock

Dortmund, Germany, 44263

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Klinikum der Ernst-Moritz-Arndt-Universität

Greifswald, Germany, 17489

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St.-Johannes-Hospital Dortmund

Dortmund, Germany, 44137

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A.O. Spedali Civili di Brescia

Brescia, Italy, 25100

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A.O.U. Ospedali Riuniti Umberto I - Lancisi - Salesi

Ancona, Italy, 60126

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IRCC di Candiolo

Candiolo, Italy, 10060

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Hospital de Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, Spain, 38009

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Hospital Universitario Virgen del Rocío

Sevilla, Spain, 41013

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Karolinska Universitetsjukhuset, Astrid Lindgren Barnsjukhus

Stockholm, Sweden, 17176

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Samsung Medical Center

Seoul, South Korea, 135-710

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Chonbuk National University Hospital

Jeonbuk, South Korea, 561-712

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Guro Hospital of Korea University

Seoul,, South Korea, 152-703

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Inselspital Bern

Bern, Switzerland, 3010

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Kantonsspital St. Gallen

St. Gallen, Switzerland, 9007

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Luzerner Kantonsspital

Luzern, Switzerland, 6000

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Prince of Songkla University

Songkhla, Thailand, 90110

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Yonsei University Hospital

Seoul, South Korea

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Seoul National University Hospital

Seoul, South Korea, 110-744

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Hôpital Cantonal Universitaire de Genève

Genève, Switzerland, 1211

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Universitätsspital Basel

Basel, Switzerland, 4031

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Siriraj Hospital, Mahidol

Bangkok, Thailand, 10700

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Krankenhaus Dresden-Friedrichstadt

Dresden, Germany, 01067

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St. Josefs-Hospital

Dortmund, Germany, 44263

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St.-Johannes-Hospital Dortmund

Dortmund, Germany, 44137

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Asan Medical Center

Seoul, South Korea, 138-736

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Chonnam National University Hwasun Hospital

Hwasun, South Korea, 519809

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Seoul National University Hospital

Gyeunggi-do, South Korea, 463-707

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A.O.U. Seconda Università

Napoli, Italy, 80138

Trial Design