E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Focal Liver Lesions in Diagnosed Cancer Patients |
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E.1.1.1 | Medical condition in easily understood language |
Liver Lesions in Cancer Patients |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028049 |
E.1.2 | Term | MRI |
E.1.2 | System Organ Class | 10022891 - Investigations |
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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 |
to assess the diagnostic accuracy of focal liver lesion detection by MRI following administration of CMC-001 and diffusion weighted imaging (DWI) of the liver in diagnosed cancer patients. For comparative purposes, data from standard of care examination by MRI following administration of gadoxetic acid and DWI of the liver will be used. |
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E.2.2 | Secondary objectives of the trial |
to further evaluate the safety and tolerability of CMC 001 in diagnosed cancer patients. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The study will include male or female cancer patients with focal liver lesions, aged 18 years or older, who have performed a standard of care MRI examination of the liver with gadoxetic acid (Primovist) and DWI of the liver at least 7 days prior to inclusion (Visit 1). |
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E.4 | Principal exclusion criteria |
1) Known or suspected hypersensitivity or allergy to the IMP, or to chemically related products.
2) Clinically relevant medical history or abnormal physical findings that could interfere with the safety of the patient or the objectives of the study, as judged by the Investigator.
3) Concurrent severe illness in the gastrointestinal tract like paralysis or malabsorption, or clinically manifested jaundice.
4) Known or suspected clinically severe concurrent illness that might influence the renal function or the patient had undergone kidney, liver or bone marrow transplantation.
5) Known liver cirrhosis, severely reduced liver function (Child-Pugh class C), icteric obstructive hepatobiliary disease or portosystemic shunt.
6) Female patients currently pregnant or breast-feeding. Female patients of childbearing potential (i.e. female patients who have not been post-menopausal for more than one year or who have not undergone sterilisation) must have a negative urine pregnancy test.
7) Contraindications to MR imaging (e.g. aneurysm clip, pacemaker, or severe claustrophobia).
8) Uncompensated cardiac failure (cardiac failure New York Heart Association grade 4 [NYHA IV]).
9) Ongoing treatment with tetracycline or doxycycline.
10) Use of antidiarrhoea or antinausea drugs during the last 7 days preceding this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
to assess diagnostic accuracy of method performance |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
safety and tolerability of CMC-001 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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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the date of the last patient’s last visit, including the telephone follow-up, or the date of recording of “reference of pathology data” in the case report form (CRF), if available, which ever is latest. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |