Health Economic Evaluation of Primovist-enhanced Liver MRI

Bayer

Status and phase

Completed

Phase 4

Conditions

Neoplasm Metastasis

Colorectal Neoplasms

Treatments

Procedure: Contrast-enhanced CT

Procedure: Primovist MRI

Procedure: Extracellular contrast media (ECCM) MRI

Study type

Interventional

Funder types

Industry

Identifiers

NCT00764621

312041 (Other Identifier)

91789

2008-000583-16 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

360 patients

Sex

All

Ages

18+ years old

Volunteers

No 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