Health Economic Evaluation of Primovist-enhanced Liver MRI
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00764621
First received: October 1, 2008
Last updated: December 17, 2012
Last verified: December 2012
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Neoplasms Neoplasm Metastasis |
Procedure: Primovist MRI Procedure: Extracellular contrast media (ECCM) MRI Procedure: Contrast-enhanced CT |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- 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. [ Time Frame: At end of the study (per patient) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of patients with intra-operatively modified surgical plans based on initial imaging with either Primovist-, ECCM-MRI or CE-CT [ Time Frame: After end of the study ] [ Designated as safety issue: No ]
| Enrollment: | 361 |
| Study Start Date: | October 2008 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Procedure: Primovist MRI
Contrast-enhanced MRI with an i.v. application of Primovist in the approved dosage
|
| Active Comparator: Arm 2 |
Procedure: Extracellular contrast media (ECCM) MRI
Contrast-enhanced MRI with an i.v. application of an approved extracellular contrast medium in the approved dosage
|
| Active Comparator: Arm 3 |
Procedure: Contrast-enhanced CT
Contrast-enhanced 3 phase multidetector CT with an i.v. application of an approved iodinated contrast medium in the approved dosage
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764621
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Hide Study LocationsLocations
| Austria | |
| Graz, Austria, 8036 | |
| Wien, Austria, 1030 | |
| Wien, Austria, 1090 | |
| Germany | |
| Karlsruhe, Baden-Württemberg, Germany, 76133 | |
| Tübingen, Baden-Württemberg, Germany, 72076 | |
| München, Bayern, Germany, 81377 | |
| München, Bayern, Germany, 81675 | |
| Frankfurt, Hessen, Germany, 60596 | |
| Greifswald, Mecklenburg-Vorpommern, Germany, 17489 | |
| Dortmund, Nordrhein-Westfalen, Germany, 44137 | |
| Dortmund, Nordrhein-Westfalen, Germany, 44263 | |
| Magdeburg, Sachsen-Anhalt, Germany, 39112 | |
| Dresden, Sachsen, Germany, 01067 | |
| Berlin, Germany, 10117 | |
| Italy | |
| Candiolo, Torino, Italy, 10060 | |
| Ancona, Italy, 60126 | |
| Bologna, Italy, 40138 | |
| Brescia, Italy, 25100 | |
| Chieti, Italy, 66100 | |
| Napoli, Italy, 80138 | |
| Korea, Republic of | |
| Seoul,, Korea, Korea, Republic of, 152-703 | |
| Gyeunggi-do, South Korea, Korea, Republic of, 463-707 | |
| Hwasun, Korea, Republic of, 519809 | |
| Jeonbuk, Korea, Republic of, 561-712 | |
| Seoul, Korea, Republic of, 138-736 | |
| Seoul, Korea, Republic of, 135-710 | |
| Seoul, Korea, Republic of, 110-744 | |
| Seoul, Korea, Republic of | |
| Netherlands | |
| Amsterdam, Netherlands, 1066CX | |
| Leiden, Netherlands, 2333 ZA | |
| Utrecht, Netherlands, 3584 CX | |
| Spain | |
| Santa Cruz de Tenerife, Canarias, Spain, 38009 | |
| Barcelona, Spain, 08036 | |
| Sevilla, Spain, 41013 | |
| Sweden | |
| Stockholm, Sweden, 182 88 | |
| Stockholm, Sweden, 17176 | |
| Uppsala, Sweden, 75185 | |
| Switzerland | |
| Basel, Basel-Stadt, Switzerland, 4031 | |
| St. Gallen, Sankt Gallen, Switzerland, 9007 | |
| Bern, Switzerland, 3010 | |
| Genève, Switzerland, 1211 | |
| Luzern, Switzerland, 6000 | |
| Thailand | |
| Bangkok, Thailand, 10700 | |
| Songkhla, Thailand, 90110 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Affairs Therapeutic Area Head, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT00764621 History of Changes |
| Other Study ID Numbers: | 91789, 312041, 2008-000583-16 |
| Study First Received: | October 1, 2008 |
| Last Updated: | December 17, 2012 |
| Health Authority: | Austria: Federal Office for Safety in Health Care Germany: Federal Institute for Drugs and Medical Devices Italy: Ministry of Health Korea: Food and Drug Administration Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Spain: Spanish Agency of Medicines Sweden: Medical Products Agency Switzerland: Swissmedic Thailand: Food and Drug Administration |
Keywords provided by Bayer:
|
Gadolinium ethoxybenzyl DTPA Contrast media Outcome Assessment (Health Care) |
Magnetic Resonance Imaging Tomography, X-Ray Computed Liver |
Additional relevant MeSH terms:
|
Neoplasms Colorectal Neoplasms Neoplasm Metastasis Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013