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 extra-cellular 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 - Primovist VALUE Study

• Register: EUCTR
• Last refreshed on: 24 April 2012
• Main ID: EUCTR2008-000583-16-IT
• Date of registration: 09/03/2009
• Prospective Registration: No
• Primary sponsor: BAYER SCHERING PHARMA AG
• Public 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 extra-cellular 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 - Primovist VALUE Study
• Scientific 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 extra-cellular 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 - Primovist VALUE Study
• Date of first enrolment: 03/02/2009
• Target sample size: 660
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000583-16
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Austria, Germany, Italy, Netherlands, Spain, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
The following patients are to be included in this study: 1. Patients with known or suspected metachronous liver metastases secondary to colorectal cancer who are scheduled for further contrast-enhanced tomographic imaging 2. Patients willing to undergo the study procedures 3. Patients who are fully informed about the study and have signed the informed consent form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Patients with the following conditions are to be excluded from this study: 1. Patients (men or women) under 18 years of age 2. Patients who have previously entered this study 3. 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 4. Patients who have received or will receive any investigational drug 48 hours before injection of the study drug or during study participation 5. Women who are pregnant, lactating or who are of childbearing potential and have not had a negative urine pregnancy test at baseline visit(s) 6. Patients not eligible to contrast media (CM) injection according to product labeling 7. Patients scheduled for liver-specific MRI other than Primovist-enhanced MRI, e.g. Multihance-, Teslascan- or SPIO-enhanced MRI 8. Patients who require emergency treatment 9. Patients who are clinically unstable and whose clinical course is unpredictable (e.g. due to previous surgery, acute myocardial infarction) 10. Patients with any physical or mental status that interferes with the signing of informed consent 11. Patients with known anaphylactoid or anaphylactic reaction to any contrast media or hypersensitivity to any allergen including drugs 12. Patients with a contraindication for MRI or CT. 13. Patients with impaired renal function (e.g. acute renal failure) or patients on dialysis. 14. Close affiliation with the investigational site; e.g., a relative of the investigator, dependent person (e.g., employee or student of the investigational site)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with history of colorectal cancer and known or suspected metachronous liver metastasis(es) scheduled to undergo contrast-enhanced tomographic imaging (i.e. CE-MRI or CE-CT) of the liver.
MedDRA version: 9.1 Level: LLT Classification code 10052358 Term: Colorectal cancer metastatic

Intervention(s)

Trade Name: PRIMOVIST
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Gadoxetic acid
Concentration unit: mmol/kg millimole(s)/kilogram
Concentration type: equal
Concentration number: .025-

Primary Outcome(s)

Main Objective: The main objective of this study is to evaluate outcomes and resource needs of imaging and treatment following Primovist-enhanced MRI (PV-MRI) as compared to ECCM-enhanced MRI (ECCM-MRI) and contrast-enhanced CT (CE-CT) in patients with a history of colorectal cancer and known or suspected metachronous liver metastases, based on the evalua¬tion of the following: Proportion of patients for whom further imaging is required to come to a therapy decision after initial imaging of the liver with either PV-MRI, ECCM-MRI or CE-CT (primary efficacy variable) Proportion of patients with intra-operatively modified surgical plans based on either PV-MRI, ECCM-MRI or CE-CT Diagnostic performance of either PV-MRI, ECCM-MRI or CE-CT in comparison to final diagnosis Confidence in diagnosis and therapeutic decision Resource needs for imaging and treatment after either PV-MRI, ECCM-MRI or CE-CT

Primary end point(s): None

Secondary Objective: To assess safety of PV-MRI as compared to ECCM-MRI and CE-CT in patients with known or suspected liver metastases based on the evaluation adverse events.

Secondary ID(s)

312041

2008-000583-16-AT