check_circleStudy Completed

Colorectal Neoplasms, Neoplasm Metastasis

Bayer Identifier:

91789

ClinicalTrials.gov Identifier:

NCT00764621

EudraCT Number:

2008-000583-16

EU CT Number:

Not Available
Health economic evaluation of Primovist-enhanced liver MRI

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Patients with known or suspected metachronous liver metastases secondary to colorectal cancer who are scheduled for further contrast-enhanced tomographic imaging
  • - 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
October 2008 - November 2010
Phase
Phase 4
Could I Receive a placebo
No
Products
Eovist/Primovist (Gadoxetate disodium, BAY86-4873)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Klinikum Großhadern der Ludwig-Maximilians-UniversitätMünchen, 81377, Germany
Completed
Universitätsklinikum Otto-von Guericke - MagdeburgMagdeburg, 39112, Germany
Completed
Klinikum der Eberhard-Karls-Universität TübingenTübingen, 72076, Germany
Completed
AUSL Chieti - AbruzzoChieti, 66100, Italy
Completed
A.O.U. Policlinico S.Orsola-MalpighiBologna, 40138, Italy
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Terminated
University Medical Center UtrechtUTRECHT, 3584 CX, Netherlands
Terminated
Nederlands Kanker InstituutAmsterdam, 1066CX, Netherlands
Terminated
Leids Universitair Medisch CentrumLeiden, 2333 ZA, Netherlands
Completed
Danderyds sjukhusStockholm, 182 88, Sweden
Completed
Akademiska SjukhusetUppsala, 75185, Sweden
Completed
Allgemeines Krankenhaus der Stadt Wien UniversitätsklinikenWien, 1090, Austria
Completed
Krankenanstalt der Stadt Wien - RudolfstiftungWien, 1030, Austria
Completed
Medizinische Universität GrazGraz, 8036, Austria
Completed
Universitätsklinikum Charite zu BerlinBerlin, 10117, Germany
Completed
Klinikum rechts der IsarMünchen, 81675, Germany
Completed
Städtisches Klinikum Karlsruhe gGmbHKarlsruhe, 76133, Germany
Completed
Klinikum der Johann Wolfgang Goethe UniversitätFrankfurt, 60596, Germany
Terminated
Medizinisches Versorgungszentrum Prof. Dr. D. UhlenbrockDortmund, 44263, Germany
Completed
Klinikum der Ernst-Moritz-Arndt-UniversitätGreifswald, 17489, Germany
Terminated
St.-Johannes-Hospital DortmundDortmund, 44137, Germany
Completed
A.O. Spedali Civili di BresciaBrescia, 25100, Italy
Terminated
A.O.U. Ospedali Riuniti Umberto I - Lancisi - SalesiAncona, 60126, Italy
Completed
IRCC di CandioloCandiolo, 10060, Italy
Completed
Hospital de Nuestra Señora de la CandelariaSanta Cruz de Tenerife, 38009, Spain
Completed
Hospital Universitario Virgen del RocíoSevilla, 41013, Spain
Terminated
Karolinska Universitetsjukhuset, Astrid Lindgren BarnsjukhusStockholm, 17176, Sweden
Completed
Samsung Medical CenterSeoul, 135-710, Korea, Republic Of
Completed
Chonbuk National University HospitalJeonbuk, 561-712, Korea, Republic Of
Completed
Guro Hospital of Korea UniversitySeoul,, 152-703, Korea, Republic Of
Completed
Inselspital BernBern, 3010, Switzerland
Terminated
Kantonsspital St. GallenSt. Gallen, 9007, Switzerland
Terminated
Luzerner KantonsspitalLuzern, 6000, Switzerland
Completed
Prince of Songkla UniversitySongkhla, 90110, Thailand
Completed
Yonsei University HospitalSeoul, Korea, Republic Of
Completed
Seoul National University HospitalSeoul, 110-744, Korea, Republic Of
Completed
Hôpital Cantonal Universitaire de GenèveGenève, 1211, Switzerland
Completed
Universitätsspital BaselBasel, 4031, Switzerland
Completed
Siriraj Hospital, MahidolBangkok, 10700, Thailand
Completed
Krankenhaus Dresden-FriedrichstadtDresden, 01067, Germany
Completed
St. Josefs-HospitalDortmund, 44263, Germany
Completed
St.-Johannes-Hospital DortmundDortmund, 44137, Germany
Completed
Asan Medical CenterSeoul, 138-736, Korea, Republic Of
Completed
Chonnam National University Hwasun HospitalHwasun, 519809, Korea, Republic Of
Completed
Seoul National University HospitalGyeunggi-do, 463-707, Korea, Republic Of
Completed
A.O.U. Seconda UniversitàNapoli, 80138, Italy

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.
    date_rangeTime Frame:
    At end of the study (per patient)
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Proportion of patients with intra-operatively modified surgical plans based on initial imaging with either Primovist-, ECCM-MRI or CE-CT
    date_rangeTime Frame:
    After end of the study
    enhanced_encryption
    Safety Issue:
    no

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

Additional Information

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