Trial Condition(s):
Colorectal Neoplasms, Neoplasm Metastasis
Health economic evaluation of Primovist-enhanced liver MRI
Bayer Identifier:
91789
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Klinikum Großhadern der Ludwig-Maximilians-Universität München, Germany, 81377 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Otto-von Guericke - Magdeburg Magdeburg, Germany, 39112 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Eberhard-Karls-Universität Tübingen Tübingen, Germany, 72076 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL Chieti - Abruzzo Chieti, Italy, 66100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico S.Orsola-Malpighi Bologna, Italy, 40138 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University Medical Center Utrecht UTRECHT, Netherlands, 3584 CX | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nederlands Kanker Instituut Amsterdam, Netherlands, 1066CX | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Leids Universitair Medisch Centrum Leiden, Netherlands, 2333 ZA | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Danderyds sjukhus Stockholm, Sweden, 182 88 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Akademiska Sjukhuset Uppsala, Sweden, 75185 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Allgemeines Krankenhaus der Stadt Wien Universitätskliniken Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Krankenanstalt der Stadt Wien - Rudolfstiftung Wien, Austria, 1030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Charite zu Berlin Berlin, Germany, 10117 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum rechts der Isar München, Germany, 81675 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Städtisches Klinikum Karlsruhe gGmbH Karlsruhe, Germany, 76133 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Johann Wolfgang Goethe Universität Frankfurt, Germany, 60596 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinisches Versorgungszentrum Prof. Dr. D. Uhlenbrock Dortmund, Germany, 44263 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Ernst-Moritz-Arndt-Universität Greifswald, Germany, 17489 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St.-Johannes-Hospital Dortmund Dortmund, Germany, 44137 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Spedali Civili di Brescia Brescia, Italy, 25100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Ospedali Riuniti Umberto I - Lancisi - Salesi Ancona, Italy, 60126 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCC di Candiolo Candiolo, Italy, 10060 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de Nuestra Señora de la Candelaria Santa Cruz de Tenerife, Spain, 38009 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario Virgen del Rocío Sevilla, Spain, 41013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Karolinska Universitetsjukhuset, Astrid Lindgren Barnsjukhus Stockholm, Sweden, 17176 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Samsung Medical Center Seoul, South Korea, 135-710 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chonbuk National University Hospital Jeonbuk, South Korea, 561-712 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Guro Hospital of Korea University Seoul,, South Korea, 152-703 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Inselspital Bern Bern, Switzerland, 3010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kantonsspital St. Gallen St. Gallen, Switzerland, 9007 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Luzerner Kantonsspital Luzern, Switzerland, 6000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Prince of Songkla University Songkhla, Thailand, 90110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yonsei University Hospital Seoul, South Korea | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seoul National University Hospital Seoul, South Korea, 110-744 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Cantonal Universitaire de Genève Genève, Switzerland, 1211 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsspital Basel Basel, Switzerland, 4031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Siriraj Hospital, Mahidol Bangkok, Thailand, 10700 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Krankenhaus Dresden-Friedrichstadt Dresden, Germany, 01067 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Josefs-Hospital Dortmund, Germany, 44263 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St.-Johannes-Hospital Dortmund Dortmund, Germany, 44137 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asan Medical Center Seoul, South Korea, 138-736 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chonnam National University Hwasun Hospital Hwasun, South Korea, 519809 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seoul National University Hospital Gyeunggi-do, South Korea, 463-707 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Seconda Università Napoli, Italy, 80138 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Multi-center, randomized comparison study to eVALUatE outcomes and resource needs of imaging and treatment following Primovist-enhanced MRI of the liver in comparison to extracellular contrast media (ECCM)-enhanced MRI and contrast-enhanced computed tomography (CT) in patients with a history of colorectal cancer and known or suspected metachronous liver metastases.
Trial Type:
Interventional
Intervention Type:
Procedure/Surgery
Trial Purpose:
Diagnostic
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Primary variable is the proportion of patients in each of the three treatment groups for whom further imaging is required after initial imaging to come to a therapy decision.Timeframe: At end of the study (per patient)
Secondary Outcome
- Proportion of patients with intra-operatively modified surgical plans based on initial imaging with either Primovist-, ECCM-MRI or CE-CTTimeframe: After end of the study
Additional Information
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