E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients presenting with know or suspected enhancing abnormality(ies) and/or lesion(s) in at least one body region among head & neck, thorax (including breast), abdomen (including liver, pancreas and kidney), pelvis (invluding uterus, ovary and prostate) and musculoskeletal (including extremities) based on a previous imaging procedure performed within 12 months prior to ICF signature. |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10059696 |
E.1.2 | Term | Scan with contrast |
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 |
Primary objective 1:
To demonstrate the superiority of gadopiclenol-enhanced MRI at 0.05 mmol/kg body weight (BW) compared to unenhanced MRI for patients referred for contrast-enhanced MRI of body regions, in terms of 3 lesion visualization co-primary criteria (border delineation, internal morphology and degree of contrast enhancement) using the patient as his/her own control.
Primary objective 2:
To demonstrate the non-inferiority of gadopiclenol at 0.05 mmol/kg compared to gadobutrol at 0.1 mmol/kg in terms of 3 lesion visualization co-primary criteria (border delineation, internal morphology, degree of contrast enhancement) for patients referred for contrast-enhanced MRI of body regions.
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E.2.2 | Secondary objectives of the trial |
- To demonstrate the non-inferiority of gadopiclenol compared to gadobutrol in terms of 3 lesion visualization co-primary criteria (border delineation, internal morphology, degree of contrast enhancement) for patients referred for contrast-enhanced MRI of body regions (for FDA only).
- To assess the following parameters with gadopiclenol and gadobutrol
- Lesion visualization assessment by investigator
- Subgroup analysis by organ and/or region of the 3 lesion visualization co-primary criteria
- Improvement in lesion visualization scores at patient level
- Technical adequacy of images
- Number, size and location of lesions
- Diagnostic confidence
- Impact of contrast-enhanced MRI on patient treatment plan
- Percentage enhancement (E%) of lesion
- Lesion to Background Ratio (LBR)
- Overall diagnostic preference
- To assess the safety profile of gadopiclenol and gadobutrol
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Female or male adult patient having reached legal majority age.
2.Patient presenting with known or suspected enhancing abnormality(ies) and/or lesion(s) in at least one body region among head & neck, thorax (including breast), abdomen (including liver, pancreas and kidney), pelvis (including uterus, ovary and prostate) and musculoskeletal (including extremities) based on a previous imaging procedure performed within 12 months prior to ICF signature. US patients are restricted to the breast in compliance with local approved indications of gadobutrol.
3.Patient scheduled for a contrast-enhanced MRI examination of a body region for clinical reasons and agreeing to have a second contrast-enhanced MRI examination for the purpose of the trial.
4.If the patient was treated (either with radiation, surgery, biopsy or other relevant treatments) between previous imaging evaluation and trial MRI, there should still be a high suspicion of remaining enhancing abnormality(ies) and/or lesion(s) on the basis of available clinical information.
5.Patient able and willing to participate in the trial.
6.Patient having read the information and having provided his/her consent to participate in writing by dating and signing the informed consent prior to any trial related procedure being conducted.
7.Patient affiliated to national health insurance according to local regulatory requirements.
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E.4 | Principal exclusion criteria |
1.Patients with known or suspected lesion(s) referred for contrast-enhanced MRI of CNS or of heart or for MR Angiography.
2.Patient presenting with known class III/IV congestive heart failure according to the New York Heart Association classification (NYHA).
3.Patient having received any investigational medicinal product within 7 days prior to trial entry or scheduled to receive any investigational treatment in the course of the trial.
4.Patient previously randomized in this trial.
5.Patient presenting with any contraindication to MRI examinations.
6.Patient having received any contrast agent (for MRI or CT) within 3 days prior to trial products administration, or scheduled to receive any contrast agent during the course of the trial or within 24 hours after the second trial product administration.
7.Patient expected/scheduled to have any treatment or medical procedure (e.g. chemotherapy, radiotherapy, biopsy or surgery etc…) that may impact the aspects of the imaged lesions between the 2 MRI examinations. (Patients under corticosteroids and/or maintenance chemotherapy with a stable dose at the time of screening visit and throughout the trial can be included).
8.Patient with anticipated, current or past condition (medical, psychological, social or geographical) that would compromise the patient’s safety or her/his ability to participate in the trial.
9.Patient unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits and/or unlikelihood of completing the trial.
10.Patient related to the Investigator or any other trial staff or relative directly involved in the trial conduct.
11.Patient presenting with acute or chronic renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m² assessed within 1 day prior to each contrast agent administration.
12.Pregnant or breast-feeding female patient (a female patient of childbearing potential or with amenorrhea for less than 12 months must have a negative urine pregnancy test within 1 day prior to trial MRI and must be using highly effective birth controlled method until the last trial visit).
13.Patient with known contra-indication(s) to the use or with known sensitivity to one of the products under investigation or to other GBCAs (such as hypersensitivity, post contrast acute kidney injury).
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E.5 End points |
E.5.1 | Primary end point(s) |
Lesion visualization criteria based on 3 co-primary criteria: border delineation, internal morphology and degree of contrast enhancement, assessed on the images acquired during the MRI performed with gadopiclenol (criteria 1) and the MRI performed with gadopiclenol and those performed with gadobutrol (criteria 2) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After the second contrast injection / MRI |
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E.5.2 | Secondary end point(s) |
Vizualisation parameters with gadopiclenol and gadobutrol (e.g lesion visualization assessment by investigator, number, size and location of lesions ...)
Safety profile of gadopiclenol and gadobutrol |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After the second contrast injection/MRI
At the end of the patient's participation |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 31 |
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 | No |
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 |
Belgium |
Bulgaria |
France |
Germany |
Hungary |
Italy |
Korea, Republic of |
Mexico |
Poland |
Spain |
Ukraine |
United States |
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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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The trial is considered as completed once all the images collected for all the patients have been reviewed by all the independent blinded readers.
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |