Health Economic Evaluation of Primovist-enhanced Liver MRI
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.
3 other identifiers
interventional
360
9 countries
44
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2008
Typical duration for phase_4
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedFirst Posted
Study publicly available on registry
October 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedNovember 4, 2014
November 1, 2014
1.9 years
October 1, 2008
November 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
At end of the study (per patient)
Secondary Outcomes (1)
Proportion of patients with intra-operatively modified surgical plans based on initial imaging with either Primovist-, ECCM-MRI or CE-CT
After end of the study
Study Arms (3)
Arm 1
EXPERIMENTALArm 2
ACTIVE COMPARATORArm 3
ACTIVE COMPARATORInterventions
Contrast-enhanced MRI with an i.v. application of Primovist in the approved dosage
Contrast-enhanced MRI with an i.v. application of an approved extracellular contrast medium in the approved dosage
Contrast-enhanced 3 phase multidetector CT with an i.v. application of an approved iodinated contrast medium in the approved dosage
Eligibility Criteria
You may qualify if:
- Patients with known or suspected metachronous liver metastases secondary to colorectal cancer who are scheduled for further contrast-enhanced tomographic imaging
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (44)
Unknown Facility
Vienna, Vienna, 1090, Austria
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Graz, 8036, Austria
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Vienna, 1030, Austria
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Karlsruhe, Baden-Wurttemberg, 76133, Germany
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Tübingen, Baden-Wurttemberg, 72076, Germany
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München, Bavaria, 81377, Germany
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München, Bavaria, 81675, Germany
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Frankfurt am Main, Hesse, 60596, Germany
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Greifswald, Mecklenburg-Vorpommern, 17489, Germany
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Dortmund, North Rhine-Westphalia, 44137, Germany
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Dortmund, North Rhine-Westphalia, 44263, Germany
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Dresden, Saxony, 01067, Germany
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Magdeburg, Saxony-Anhalt, 39112, Germany
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Berlin, State of Berlin, 10117, Germany
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Candiolo, Torino, 10060, Italy
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Ancona, 60126, Italy
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Bologna, 40138, Italy
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Brescia, 25100, Italy
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Chieti, 66100, Italy
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Napoli, 80138, Italy
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Amsterdam, 1066CX, Netherlands
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Leiden, 2333 ZA, Netherlands
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Utrecht, 3584 CX, Netherlands
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Seoul, Korea, 152-703, South Korea
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Gyeunggi-do, South Korea, 463-707, South Korea
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Hwasun, 519809, South Korea
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Jeonbuk, 561-712, South Korea
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Seoul, 110-744, South Korea
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Seoul, 135-710, South Korea
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Seoul, 138-736, South Korea
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Seoul, South Korea
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Barcelona, Barcelona, 08036, Spain
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Santa Cruz de Tenerife, Canary Islands, 38009, Spain
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Seville, Sevilla, 41013, Spain
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Stockholm, 17176, Sweden
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Stockholm, 182 88, Sweden
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Uppsala, 75185, Sweden
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Basel, Canton of Basel-City, 4031, Switzerland
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Geneva, Canton of Geneva, 1211, Switzerland
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Lucerne, Canton of Lucerne, 6000, Switzerland
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Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
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Bern, 3010, Switzerland
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Bangkok, 10700, Thailand
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Songkhla, 90110, Thailand
Related Publications (1)
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.
PMID: 24652690DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2008
First Posted
October 2, 2008
Study Start
October 1, 2008
Primary Completion
September 1, 2010
Study Completion
November 1, 2010
Last Updated
November 4, 2014
Record last verified: 2014-11