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

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

Loading...
Locations
Status
LocationsStatus
Locations

Klinikum Großhadern der Ludwig-Maximilians-Universität

München, Germany, 81377

Status
Completed
 
Locations

Universitätsklinikum Otto-von Guericke - Magdeburg

Magdeburg, Germany, 39112

Status
Completed
 
Locations

Klinikum der Eberhard-Karls-Universität Tübingen

Tübingen, Germany, 72076

Status
Completed
 
Locations

AUSL Chieti - Abruzzo

Chieti, Italy, 66100

Status
Completed
 
Locations

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

Bologna, Italy, 40138

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

University Medical Center Utrecht

UTRECHT, Netherlands, 3584 CX

Status
Terminated
 
Locations

Nederlands Kanker Instituut

Amsterdam, Netherlands, 1066CX

Status
Terminated
 
Locations

Leids Universitair Medisch Centrum

Leiden, Netherlands, 2333 ZA

Status
Terminated
 
Locations

Danderyds sjukhus

Stockholm, Sweden, 182 88

Status
Completed
 
Locations

Akademiska Sjukhuset

Uppsala, Sweden, 75185

Status
Completed
 
Locations

Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Wien, Austria, 1090

Status
Completed
 
Locations

Krankenanstalt der Stadt Wien - Rudolfstiftung

Wien, Austria, 1030

Status
Completed
 
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Completed
 
Locations

Universitätsklinikum Charite zu Berlin

Berlin, Germany, 10117

Status
Completed
 
Locations

Klinikum rechts der Isar

München, Germany, 81675

Status
Completed
 
Locations

Städtisches Klinikum Karlsruhe gGmbH

Karlsruhe, Germany, 76133

Status
Completed
 
Locations

Klinikum der Johann Wolfgang Goethe Universität

Frankfurt, Germany, 60596

Status
Completed
 
Locations

Medizinisches Versorgungszentrum Prof. Dr. D. Uhlenbrock

Dortmund, Germany, 44263

Status
Terminated
 
Locations

Klinikum der Ernst-Moritz-Arndt-Universität

Greifswald, Germany, 17489

Status
Completed
 
Locations

St.-Johannes-Hospital Dortmund

Dortmund, Germany, 44137

Status
Terminated
 
Locations

A.O. Spedali Civili di Brescia

Brescia, Italy, 25100

Status
Completed
 
Locations

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

Ancona, Italy, 60126

Status
Terminated
 
Locations

IRCC di Candiolo

Candiolo, Italy, 10060

Status
Completed
 
Locations

Hospital de Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, Spain, 38009

Status
Completed
 
Locations

Hospital Universitario Virgen del Rocío

Sevilla, Spain, 41013

Status
Completed
 
Locations

Karolinska Universitetsjukhuset, Astrid Lindgren Barnsjukhus

Stockholm, Sweden, 17176

Status
Terminated
 
Locations

Samsung Medical Center

Seoul, South Korea, 135-710

Status
Completed
 
Locations

Chonbuk National University Hospital

Jeonbuk, South Korea, 561-712

Status
Completed
 
Locations

Guro Hospital of Korea University

Seoul,, South Korea, 152-703

Status
Completed
 
Locations

Inselspital Bern

Bern, Switzerland, 3010

Status
Completed
 
Locations

Kantonsspital St. Gallen

St. Gallen, Switzerland, 9007

Status
Terminated
 
Locations

Luzerner Kantonsspital

Luzern, Switzerland, 6000

Status
Terminated
 
Locations

Prince of Songkla University

Songkhla, Thailand, 90110

Status
Completed
 
Locations

Yonsei University Hospital

Seoul, South Korea

Status
Completed
 
Locations

Seoul National University Hospital

Seoul, South Korea, 110-744

Status
Completed
 
Locations

Hôpital Cantonal Universitaire de Genève

Genève, Switzerland, 1211

Status
Completed
 
Locations

Universitätsspital Basel

Basel, Switzerland, 4031

Status
Completed
 
Locations

Siriraj Hospital, Mahidol

Bangkok, Thailand, 10700

Status
Completed
 
Locations

Krankenhaus Dresden-Friedrichstadt

Dresden, Germany, 01067

Status
Completed
 
Locations

St. Josefs-Hospital

Dortmund, Germany, 44263

Status
Completed
 
Locations

St.-Johannes-Hospital Dortmund

Dortmund, Germany, 44137

Status
Completed
 
Locations

Asan Medical Center

Seoul, South Korea, 138-736

Status
Completed
 
Locations

Chonnam National University Hwasun Hospital

Hwasun, South Korea, 519809

Status
Completed
 
Locations

Seoul National University Hospital

Gyeunggi-do, South Korea, 463-707

Status
Completed
 
Locations

A.O.U. Seconda Università

Napoli, Italy, 80138

Status
Completed
 

Trial Design