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Health Economic Evaluation of Primovist-enhanced Liver MRI

Primary Purpose

Colorectal Neoplasms, Neoplasm Metastasis

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Primovist MRI

Extracellular contrast media (ECCM) MRI

Contrast-enhanced CT

About this trial

This is an interventional diagnostic trial for Colorectal Neoplasms focused on measuring Gadolinium ethoxybenzyl DTPA, Contrast media, Outcome Assessment (Health Care), Magnetic Resonance Imaging, Tomography, X-Ray Computed, Liver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Proportion of patients with intra-operatively modified surgical plans based on initial imaging with either Primovist-, ECCM-MRI or CE-CT

Full Information

NCT ID

NCT00764621

First Posted

October 1, 2008

Last Updated

November 3, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00764621

Brief Title

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

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Neoplasms, Neoplasm Metastasis

Keywords

Gadolinium ethoxybenzyl DTPA, Contrast media, Outcome Assessment (Health Care), Magnetic Resonance Imaging, Tomography, X-Ray Computed, Liver

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

360 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Active Comparator

Arm Title

Arm 3

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Primovist MRI

Intervention Description

Contrast-enhanced MRI with an i.v. application of Primovist in the approved dosage

Intervention Type

Procedure

Intervention Name(s)

Extracellular contrast media (ECCM) MRI

Intervention Description

Contrast-enhanced MRI with an i.v. application of an approved extracellular contrast medium in the approved dosage

Intervention Type

Procedure

Intervention Name(s)

Contrast-enhanced CT

Intervention Description

Contrast-enhanced 3 phase multidetector CT with an i.v. application of an approved iodinated contrast medium in the approved dosage

Primary Outcome Measure Information:

Title

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)

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Graz

ZIP/Postal Code

8036

Country

Austria

City

Wien

ZIP/Postal Code

1030

Country

Austria

City

Wien

ZIP/Postal Code

1090

Country

Austria

City

Karlsruhe

State/Province

Baden-Württemberg

ZIP/Postal Code

76133

Country

Germany

City

Tübingen

State/Province

Baden-Württemberg

ZIP/Postal Code

72076

Country

Germany

City

München

State/Province

Bayern

ZIP/Postal Code

81377

Country

Germany

City

München

State/Province

Bayern

ZIP/Postal Code

81675

Country

Germany

City

Frankfurt

State/Province

Hessen

ZIP/Postal Code

60596

Country

Germany

City

Greifswald

State/Province

Mecklenburg-Vorpommern

ZIP/Postal Code

17489

Country

Germany

City

Dortmund

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

44137

Country

Germany

City

Dortmund

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

44263

Country

Germany

City

Magdeburg

State/Province

Sachsen-Anhalt

ZIP/Postal Code

39112

Country

Germany

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01067

Country

Germany

City

Berlin

ZIP/Postal Code

10117

Country

Germany

City

Candiolo

State/Province

Torino

ZIP/Postal Code

10060

Country

Italy

City

Ancona

ZIP/Postal Code

60126

Country

Italy

City

Bologna

ZIP/Postal Code

40138

Country

Italy

City

Brescia

ZIP/Postal Code

25100

Country

Italy

City

Chieti

ZIP/Postal Code

66100

Country

Italy

City

Napoli

ZIP/Postal Code

80138

Country

Italy

City

Seoul,

State/Province

Korea

ZIP/Postal Code

152-703

Country

Korea, Republic of

City

Gyeunggi-do

State/Province

South Korea

ZIP/Postal Code

463-707

Country

Korea, Republic of

City

Hwasun

ZIP/Postal Code

519809

Country

Korea, Republic of

City

Jeonbuk

ZIP/Postal Code

561-712

Country

Korea, Republic of

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

City

Seoul

Country

Korea, Republic of

City

Amsterdam

ZIP/Postal Code

1066CX

Country

Netherlands

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

City

Utrecht

ZIP/Postal Code

3584 CX

Country

Netherlands

City

Santa Cruz de Tenerife

State/Province

Canarias

ZIP/Postal Code

38009

Country

Spain

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

City

Stockholm

ZIP/Postal Code

17176

Country

Sweden

City

Stockholm

ZIP/Postal Code

182 88

Country

Sweden

City

Uppsala

ZIP/Postal Code

75185

Country

Sweden

City

Basel

State/Province

Basel-Stadt

ZIP/Postal Code

4031

Country

Switzerland

City

St. Gallen

State/Province

Sankt Gallen

ZIP/Postal Code

9007

Country

Switzerland

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

City

Genève

ZIP/Postal Code

1211

Country

Switzerland

City

Luzern

ZIP/Postal Code

6000

Country

Switzerland

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

City

Songkhla

ZIP/Postal Code

90110

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

24652690

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.

Results Reference

derived

Links:

URL

http://www.clinicaltrialsregister.eu

Description

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Health Economic Evaluation of Primovist-enhanced Liver MRI

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