Clinical trial NCT00764621: Health Economic Evaluation of Primovist-enhanced Liver MRI
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Neoplasms
Neoplasm Metastasis
Keywords: Gadolinium ethoxybenzyl DTPA
Contrast media
Outcome Assessment (Health Care)
Magnetic Resonance Imaging
Tomography, X-Ray Computed
Liver
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-10-02
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: 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 outcomes:
measure: Proportion of patients with intra-operatively modified surgical plans based on initial imaging with either Primovist-, ECCM-MRI or CE-CT
timeFrame: After end of the study
Other outcomes:
Locations:
city: Graz
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Karlsruhe
country: Germany
state: Baden-Württemberg
city: Tübingen
country: Germany
state: Baden-Württemberg
city: München
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: Frankfurt
country: Germany
state: Hessen
city: Greifswald
country: Germany
state: Mecklenburg-Vorpommern
city: Dortmund
country: Germany
state: Nordrhein-Westfalen
city: Dortmund
country: Germany
state: Nordrhein-Westfalen
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Dresden
country: Germany
state: Sachsen
city: Berlin
country: Germany
city: Candiolo
country: Italy
state: Torino
city: Ancona
country: Italy
city: Bologna
country: Italy
city: Brescia
country: Italy
city: Chieti
country: Italy
city: Napoli
country: Italy
city: Seoul,
country: Korea, Republic of
state: Korea
city: Gyeunggi-do
country: Korea, Republic of
state: South Korea
city: Hwasun
country: Korea, Republic of
city: Jeonbuk
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Amsterdam
country: Netherlands
city: Leiden
country: Netherlands
city: Utrecht
country: Netherlands
city: Santa Cruz de Tenerife
country: Spain
state: Canarias
city: Barcelona
country: Spain
city: Sevilla
country: Spain
city: Stockholm
country: Sweden
city: Stockholm
country: Sweden
city: Uppsala
country: Sweden
city: Basel
country: Switzerland
state: Basel-Stadt
city: St. Gallen
country: Switzerland
state: Sankt Gallen
city: Bern
country: Switzerland
city: Genève
country: Switzerland
city: Luzern
country: Switzerland
city: Bangkok
country: Thailand
city: Songkhla
country: Thailand
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.