Health Economic Evaluation of Primovist-enhanced Liver MRI

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00764621

Collaborator

(none)

360

Enrollment

Locations

Arms

Duration (Months)

8.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasms Neoplasm Metastasis	Procedure: Primovist MRI Procedure: Extracellular contrast media (ECCM) MRI Procedure: Contrast-enhanced CT	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

360 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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 Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Procedure: Primovist MRI Contrast-enhanced MRI with an i.v. application of Primovist in the approved dosage
Active Comparator: Arm 2	Procedure: Extracellular contrast media (ECCM) MRI Contrast-enhanced MRI with an i.v. application of an approved extracellular contrast medium in the approved dosage
Active Comparator: Arm 3	Procedure: Contrast-enhanced CT Contrast-enhanced 3 phase multidetector CT with an i.v. application of an approved iodinated contrast medium in the approved dosage

Arm

Intervention/Treatment

Experimental: Arm 1

Procedure: Primovist MRI

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

Active Comparator: Arm 2

Procedure: Extracellular contrast media (ECCM) MRI

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

Active Comparator: Arm 3

Procedure: Contrast-enhanced CT

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

Outcome Measures

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. [At end of the study (per patient)]

Secondary Outcome Measures

Proportion of patients with intra-operatively modified surgical plans based on initial imaging with either Primovist-, ECCM-MRI or CE-CT [After end of the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Graz		Austria	8036
2	Wien		Austria	1030
3	Wien		Austria	1090
4	Karlsruhe	Baden-Württemberg	Germany	76133
5	Tübingen	Baden-Württemberg	Germany	72076
6	München	Bayern	Germany	81377
7	München	Bayern	Germany	81675
8	Frankfurt	Hessen	Germany	60596
9	Greifswald	Mecklenburg-Vorpommern	Germany	17489
10	Dortmund	Nordrhein-Westfalen	Germany	44137
11	Dortmund	Nordrhein-Westfalen	Germany	44263
12	Magdeburg	Sachsen-Anhalt	Germany	39112
13	Dresden	Sachsen	Germany	01067
14	Berlin		Germany	10117
15	Candiolo	Torino	Italy	10060
16	Ancona		Italy	60126
17	Bologna		Italy	40138
18	Brescia		Italy	25100
19	Chieti		Italy	66100
20	Napoli		Italy	80138
21	Seoul,	Korea	Korea, Republic of	152-703
22	Gyeunggi-do	South Korea	Korea, Republic of	463-707
23	Hwasun		Korea, Republic of	519809
24	Jeonbuk		Korea, Republic of	561-712
25	Seoul		Korea, Republic of	110-744
26	Seoul		Korea, Republic of	135-710
27	Seoul		Korea, Republic of	138-736
28	Seoul		Korea, Republic of
29	Amsterdam		Netherlands	1066CX
30	Leiden		Netherlands	2333 ZA
31	Utrecht		Netherlands	3584 CX
32	Santa Cruz de Tenerife	Canarias	Spain	38009
33	Barcelona		Spain	08036
34	Sevilla		Spain	41013
35	Stockholm		Sweden	17176
36	Stockholm		Sweden	182 88
37	Uppsala		Sweden	75185
38	Basel	Basel-Stadt	Switzerland	4031
39	St. Gallen	Sankt Gallen	Switzerland	9007
40	Bern		Switzerland	3010
41	Genève		Switzerland	1211
42	Luzern		Switzerland	6000
43	Bangkok		Thailand	10700
44	Songkhla		Thailand	90110