The main objective of this study is to evaluate outcomes and resource needs of imaging and treatment following Primovist-enhanced MRI (PV-MRI) as com¬pared to ECCM-enhanced MRI (ECCM-MRI) and contrast-enhanced CT (CE-CT) in patients with a history…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
The null hypothesis of the test for the primary efficacy variable with regard
to this proportion using PV-MRI (i.e. PPV-MRI) H0: PPV-MRI * PComparator
will be tested against the alternative hypothesis H1: PPV-MRI <
PComparator using the exact Fisher test.
The one-sided significance level will be set to 0.025. There will be three
tests:
1. Using as comparator the pooled data from ECCM- MRI and CE-CT.
2. Using as comparator the data from CE-CT.
3. Using as comparator the data from ECCM- MRI.
After examination of at least 100 patients in each study group, one interim
analysis will take place to adjust the sample size. Fisher*s combination test
will be used according to Bauer, Kieser, and Lehmacher, 1999.
Secondary outcome
Another objective of this study is 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 of adverse events.
Background summary
In patients with a history of colorectal cancer, i.e. cancer that starts in the
colon or rectum, liver metastases develop in 40 % to 50 % of patients in the
first three years after the surgical resection. High precision in detecting,
localizing, and characterizing such liver lesions is important, because the
treatment decision may have consequences for the prognosis of both life
expectancy and quality of life. Surgical resection of colorectal liver
metastases is the only potentially curative method and dramatically improves
prognosis. Therefore, the timely and correct diagnosis and the determination of
resectability are of utmost importance and the key question for diagnostic
imaging procedures of the liver in patients.
Study 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 com¬pared 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
Another objective of this study is 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.
Study design
Multi-center, randomized phase IV inter-individual (parallel-group) comparison
study.
Patients will be randomized to either undergo PV-MRI, ECCM-MRI or CE-CT.
Efficacy and safety assessments will be carried out on-site by the clinical
investigators after the imaging procedure. To determine the proportion of
patients for whom further imaging is required after initial imaging of the
liver, a consensus decision by the treating radiologist and surgeon will be
obtained.
To determine the proportion of patients with intra-operatively modified
surgical plans following initial surgical planning on the basis of the imaging
procedure(s) all available documentation on the surgical procedure and its
outcome will be collected.
Intervention
patients will be randomized in 3 groups during the first imaging procedure of
the liver: PV-MRI, ECCM-MRI or CE-CT.
In case further imaging is necessary, 1 of the 2 remaining imaging procedures
should be chosen to be performed (the procedure/contrast agent that is used
during the first procedure will be excluded in the second procedure).
Study burden and risks
The possibility exist that subjects will be asked to visit the clinic for a
second imaging procedure, to perform the imaging procedure that could have been
the first choice of the investigator in case the subject did not participate in
the trial.
Mullerstrasse 178
13353 Berlin
Germany
Mullerstrasse 178
13353 Berlin
Germany
Listed location countries
Age
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
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 severe renal impairment (eGFR value of < 30 ml/min/1.73m2).
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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-000583-16-NL |
| CCMO | NL24142.041.08 |