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| ID | Type | Description | Link |
|---|---|---|---|
| 312041 | Other Identifier | company internal | |
| 2008-000583-16 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
| |
| Arm 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primovist MRI | Procedure | Contrast-enhanced MRI with an i.v. application of Primovist in the approved dosage |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna | State of Vienna | 1090 | Austria | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24652690 | Derived | 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. |
| Label | URL |
|---|---|
| Click here and search for information of Bayer products for Europe | View source |
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| Extracellular contrast media (ECCM) MRI | Procedure | Contrast-enhanced MRI with an i.v. application of an approved extracellular contrast medium in the approved dosage |
|
| Contrast-enhanced CT | Procedure | Contrast-enhanced 3 phase multidetector CT with an i.v. application of an approved iodinated contrast medium in the approved dosage |
|
| Graz |
| 8036 |
| Austria |
| Vienna | 1030 | Austria |
| Karlsruhe | Baden-Wurttemberg | 76133 | Germany |
| Tübingen | Baden-Wurttemberg | 72076 | Germany |
| München | Bavaria | 81377 | Germany |
| München | Bavaria | 81675 | Germany |
| Frankfurt am Main | Hesse | 60596 | Germany |
| Greifswald | Mecklenburg-Vorpommern | 17489 | Germany |
| Dortmund | North Rhine-Westphalia | 44137 | Germany |
| Dortmund | North Rhine-Westphalia | 44263 | Germany |
| Dresden | Saxony | 01067 | Germany |
| Magdeburg | Saxony-Anhalt | 39112 | Germany |
| Berlin | State of Berlin | 10117 | Germany |
| Candiolo | Torino | 10060 | Italy |
| Ancona | 60126 | Italy |
| Bologna | 40138 | Italy |
| Brescia | 25100 | Italy |
| Chieti | 66100 | Italy |
| Naples | 80138 | Italy |
| Amsterdam | 1066CX | Netherlands |
| Leiden | 2333 ZA | Netherlands |
| Utrecht | 3584 CX | Netherlands |
| Seoul | Korea | 152-703 | South Korea |
| Gyeunggi-do | South Korea | 463-707 | South Korea |
| Hwasun | 519809 | South Korea |
| Jeonbuk | 561-712 | South Korea |
| Seoul | 110-744 | South Korea |
| Seoul | 135-710 | South Korea |
| Seoul | 138-736 | South Korea |
| Seoul | South Korea |
| Barcelona | Barcelona | 08036 | Spain |
| Santa Cruz de Tenerife | Canary Islands | 38009 | Spain |
| Seville | Sevilla | 41013 | Spain |
| Stockholm | 17176 | Sweden |
| Stockholm | 182 88 | Sweden |
| Uppsala | 75185 | Sweden |
| Basel | Canton of Basel-City | 4031 | Switzerland |
| Geneva | Canton of Geneva | 1211 | Switzerland |
| Lucerne | Canton of Lucerne | 6000 | Switzerland |
| Sankt Gallen | Canton of St. Gallen | 9007 | Switzerland |
| Bern | 3010 | Switzerland |
| Bangkok | 10700 | Thailand |
| Songkhla | 90110 | Thailand |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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