E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with history of colorectal cancer and known or suspected metachronous liver metastasis(es) scheduled to undergo contrast-enhanced tomographic imaging (i.e. CE-MRI or CE-CT) of the liver |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052358 |
E.1.2 | Term | Colorectal cancer metastatic |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective of this study is to evaluate outcomes and resource needs of imaging and treatment following Primovist-enhanced MRI (PV-MRI) as compared to ECCM-enhanced MRI (ECCM-MRI) and contrast-enhanced CT (CE-CT) in patients with a history of colorectal cancer and known or suspected metachronous liver metastases based on the evaluation of the following: • Proportion of patients for whom further imaging is required to come to a therapy decision after initial imaging of the liver with either PV-MRI, ECCM-MRI or CE-CT (primary efficacy variable) • Proportion of patients with intra-operatively modified surgical plans based on either PV-MRI, ECCM-MRI or CE-CT • Diagnostic performance of either PV-MRI, ECCM-MRI or CE-CT in comparison to final diagnosis • Confidence in diagnosis and therapeutic decision • Resource needs for imaging and treatment after either PV-MRI, ECCM-MRI or CE-CT
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E.2.2 | Secondary objectives of the trial |
Another objective of this study is to assess safety of PV-MRI as compared to ECCM-MRI and CE-CT in patients with a history of colorectal cancer and known or suspected liver metastases based on the evaluation of adverse events. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients with known or suspected metachronous liver metastases secondary to colorectal cancer who are scheduled for further contrast-enhanced tomographic imaging 2. Patients willing to undergo the study procedures 3. Patients who are fully informed about the study and have signed the informed consent form
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E.4 | Principal exclusion criteria |
1. Patients (men or women) under 18 years of age 2. Patients who have previously entered this study 3. 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 4. Patients who have received or will receive any investigational drug 48 hours before injection of the study drug or during study participation. 5. Women who are pregnant, lactating or who are of childbearing potential and have not had a negative urine pregnancy test at baseline visit(s). 6. Patients not eligible to contrast media (CM) injection according to product labeling 7. Patients scheduled for liver-specific MRI other than Primovist-enhanced MRI, e.g. Multihance-, Teslascan- or SPIO-enhanced MRI 8. Patients who require emergency treatment 9. Patients who are clinically unstable and whose clinical course is unpredictable (e.g. due to previous surgery, acute myocardial infarction) 10. Patients with any physical or mental status that interferes with the signing of informed consent 11. Patients with known anaphylactoid or anaphylactic reaction to any contrast media or hypersensitivity to any allergen including drugs 12. Patients with a contraindication for MRI or CT. 13. Patients with severe renal impairment (eGFR value of < 30 ml/min/1.73m2). 14. Close affiliation with the investigational site; e.g., a relative of the investigator, dependent person (e.g., employee or student of the investigational site)
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E.5 End points |
E.5.1 | Primary end point(s) |
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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Health economic evaluation (outcome and recource needs) |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 21 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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For the individual patient the study ends with the end of the follow-up period 1 h post injection (p.i.) after the last imaging. With regard to data recording, the study ends with obtaining the data on final diagnosis based on either IOUS/histopathology or clinical data obtained within 3 month after the initial imaging procedure. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |