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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2008-000583-16-NL |
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Date of registration:
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14/10/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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 - Primovist VALUE study
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Scientific title:
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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 - Primovist VALUE study |
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Date of first enrolment:
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21/04/2009 |
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Target sample size:
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660 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000583-16 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Austria
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Germany
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Italy
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Netherlands
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Spain
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Sweden
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
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:
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
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Health Condition(s) or Problem(s) studied
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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
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Intervention(s)
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Trade Name: Primovist 0.25 mmol/ml Injektionslösung, Fertigspritze
Product Name: Primovist 0,25 mmol/ml Injektionslösung, Fertigspritze
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Gadoxetic acid, disodium
CAS Number: 135326-22-6
Current Sponsor code: ZK 139834
Other descriptive name: Gd-EOB-DTPA
Concentration unit: mmol/kg millimole(s)/kilogram
Concentration type: equal
Concentration number: 0.025-
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Primary Outcome(s)
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Secondary Objective: Another objective of this study is to assess safety of PV-MRI as compared to ECCM-MRI and CE-CT in patients with a history of colorectal cancer and known or suspected liver metastases based on the evaluation of adverse events.
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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 evaluation 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
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Primary end point(s): 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
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Secondary ID(s)
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2008-000583-16-AT
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312041
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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