Health Economic Evaluation of Primovist-enhanced Liver MRI

Bayer360 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

360

Conditions

Colorectal Neoplasms Neoplasm Metastasis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (44)

Unnamed facility

Vienna, Vienna, Austria

Unnamed facility

Graz, Austria

Unnamed facility

Vienna, Austria

Unnamed facility

Karlsruhe, Baden-Wurttemberg, Germany

Unnamed facility

Tübingen, Baden-Wurttemberg, Germany

Unnamed facility

Outcomes

Primary Outcomes

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 Outcomes

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