Colorectal NeoplasmsPhase 4NCT00764621
Health Economic Evaluation of Primovist-enhanced Liver MRI
A Phase 4 study testing Primovist MRI, Extracellular contrast media (ECCM) MRI and Contrast-enhanced CT in people with Colorectal Neoplasms and Neoplasm Metastasis, run by Bayer at 44 sites in 9 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Neoplasm Metastasis
- What is being tested?
- Primovist MRI, Extracellular contrast media (ECCM) MRI and Contrast-enhanced CT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 44 sitesin 9 countries
- Study dates
- Oct 2008to Nov 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with known or suspected metachronous liver metastases secondary to colorectal cancer who are scheduled for further contrast-enhanced tomographic imaging
Who cannot join
- 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)
Show all 9Show fewer
- 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 locations and contacts
44 sites in 9 countries.
44 sites in 9 countries
Germany11 sites
Study site
Berlin, State of Berlin, 10117
Study site
Dortmund, North Rhine-Westphalia, 44137
Study site
Dortmund, North Rhine-Westphalia, 44263
Study site
Dresden, Saxony, 01067
Study site
Frankfurt am Main, Hesse, 60596
Study site
Greifswald, Mecklenburg-Vorpommern, 17489
Study site
Karlsruhe, Baden-Wurttemberg, 76133
Study site
Magdeburg, Saxony-Anhalt, 39112
Study site
München, Bavaria, 81377
Study site
München, Bavaria, 81675
Study site
Tübingen, Baden-Wurttemberg, 72076
South Korea8 sites
Study site
Gyeunggi-do, South Korea, 463-707
Study site
Hwasun, 519809
Study site
Jeonbuk, 561-712
Study site
Seoul, Korea, 152-703
Study site
Seoul, 110-744
Study site
Seoul, 135-710
Study site
Seoul, 138-736
Study site
Seoul
Italy6 sites
Study site
Ancona, 60126
Study site
Bologna, 40138
Study site
Brescia, 25100
Study site
Candiolo, Torino, 10060
Study site
Chieti, 66100
Study site
Naples, 80138
Switzerland5 sites
Study site
Basel, Canton of Basel-City, 4031
Study site
Bern, 3010
Study site
Geneva, Canton of Geneva, 1211
Study site
Lucerne, Canton of Lucerne, 6000
Study site
Sankt Gallen, Canton of St. Gallen, 9007
Austria3 sites
Study site
Graz, 8036
Study site
Vienna, State of Vienna, 1090
Study site
Vienna, 1030
Netherlands3 sites
Study site
Amsterdam, 1066CX
Study site
Leiden, 2333 ZA
Study site
Utrecht, 3584 CX
Spain3 sites
Study site
Barcelona, Barcelona, 08036
Study site
Santa Cruz de Tenerife, Canary Islands, 38009
Study site
Seville, Sevilla, 41013
Sweden3 sites
Study site
Stockholm, 17176
Study site
Stockholm, 182 88
Study site
Uppsala, 75185
About this study
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.
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.
- Conditions
- Colorectal Neoplasms, Neoplasm Metastasis
- Being tested
- Primovist MRI, Extracellular contrast media (ECCM) MRI, Contrast-enhanced CT
- Keywords
- Gadolinium ethoxybenzyl DTPA, Contrast media, Outcome Assessment (Health Care), Magnetic Resonance Imaging, Tomography, X-Ray Computed, Liver
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primovist MRIProcedure or surgery
Contrast-enhanced MRI with an i.v. application of Primovist in the approved dosage
Extracellular contrast media (ECCM) MRIProcedure or surgery
Contrast-enhanced MRI with an i.v. application of an approved extracellular contrast medium in the approved dosage
Contrast-enhanced CTProcedure or surgery
Contrast-enhanced 3 phase multidetector CT with an i.v. application of an approved iodinated contrast medium in the approved dosage
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Procedure: Primovist MRI |
| Arm 2 | Active comparator | Not described Receives: Procedure: Extracellular contrast media (ECCM) MRI |
| Arm 3 | Active comparator | Not described Receives: Procedure: Contrast-enhanced CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At end of the study (per patient)
Secondary outcomes (1)
Proportion of patients with intra-operatively modified surgical plans based on initial imaging with either Primovist-, ECCM-MRI or CE-CT
Measured: After end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionSep 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764621
- Sponsor's protocol ID
- 91789
- Other IDs
- 312041, 2008-000583-16, 2008
- Status last verified
- Nov 2014
- First submitted
- 1 Oct 2008
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24652690
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00764621
- Acronym / sponsor ID
- 91789
- Conditions
- Colorectal Neoplasms, Neoplasm Metastasis
- Keywords
- Gadolinium ethoxybenzyl DTPA, Contrast media, Outcome Assessment (Health Care), Magnetic Resonance Imaging, Tomography, X-Ray Computed, Liver
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 2 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Procedure: Primovist MRI |
| Arm 2 | Active comparator | Procedure: Extracellular contrast media (ECCM) MRI |
| Arm 3 | Active comparator | Procedure: Contrast-enhanced CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with known or suspected metachronous liver metastases secondary to colorectal cancer who are scheduled for further contrast-enhanced tomographic imaging
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primovist MRIContrast-enhanced MRI with an i.v. application of Primovist in the approved dosage | Procedure or surgery | Arm 1 |
| Extracellular contrast media (ECCM) MRIContrast-enhanced MRI with an i.v. application of an approved extracellular contrast medium in the approved dosage | Procedure or surgery | Arm 2 |
| Contrast-enhanced CTContrast-enhanced 3 phase multidetector CT with an i.v. application of an approved iodinated contrast medium in the approved dosage | Procedure or surgery | Arm 3 |
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.
Time frame: At end of the study (per patient)
1 secondary outcome
Proportion of patients with intra-operatively modified surgical plans based on initial imaging with either Primovist-, ECCM-MRI or CE-CT
Time frame: After end of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2014.
- Derived from this study: PubMed 24652690Zech 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.
- Click here and search for information of Bayer products for EuropeLink provided by the sponsor.
Related trials for Colorectal Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
44 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Primovist MRI, Extracellular contrast media (ECCM) MRI and Contrast-enhanced CT in people with Colorectal Neoplasms and Neoplasm Metastasis, run by Bayer at 44 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Germany, South Korea, Italy, Switzerland, Austria and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: At end of the study (per patient)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00764621, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2014.