Clinical Trials Register

Summary
EudraCT Number:	2022-002720-12
Sponsor's Protocol Code Number:	GDX-44-016
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2023-01-19
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Hungary - National Institute of Pharmacy

A.2

EudraCT number

2022-002720-12

A.3

Full title of the trial

Performance of Elucirem® (gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) perfusion of brain gliomas

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study looking at the performance of Elucirem® (gadopiclenol) when used for advanced radiological examinations of brain gliomas.

A.4.1

Sponsor's protocol code number

GDX-44-016

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Guerbet
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Guerbet
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Guerbet
B.5.2	Functional name of contact point	Global Regulatory Pharmacist
B.5.3	Address:
B.5.3.1	Street Address	B.P. 57400
B.5.3.2	Town/ city	Roissy CdG Cedex
B.5.3.3	Post code	95943
B.5.3.4	Country	France
B.5.4	Telephone number	+33 1 45 91 69 34
B.5.6	E-mail	francois-xavier.renault@guerbet.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Elucirem
D.2.1.1.2	Name of the Marketing Authorisation holder	Guerbet
D.2.1.2	Country which granted the Marketing Authorisation	United States
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Elucirem
D.3.2	Product code	P03277/G03277
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Gadopiclenol
D.3.9.1	CAS number	933983-75-6
D.3.9.2	Current sponsor code	P03277/G03277
D.3.9.4	EV Substance Code	SUB194566
D.3.10	Strength
D.3.10.1	Concentration unit	mol/l mole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Dotarem
D.2.1.1.2	Name of the Marketing Authorisation holder	GUERBET
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Dotarem 0.5 mol/l, solution for injection in vials
D.3.2	Product code	G449.06
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Gadoteric acid
D.3.9.1	CAS number	72573-82-1
D.3.9.2	Current sponsor code	G449.06
D.3.9.4	EV Substance Code	SUB07865MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mol/l mole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Paramagnetic contrast agent

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Naive or recurrent primary glial tumor

E.1.1.1

Medical condition in easily understood language

Patients with glial tumor scheduled to undergo Magnetic Resonance Imaging (MRI)

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	24.0
E.1.2	Level	LLT
E.1.2	Classification code	10056941
E.1.2	Term	MRI brain
E.1.2	System Organ Class	100000004848

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To demonstrate the non-inferiority of DSC-MRI perfusion using Elucirem® at 0.05 mmol/kg compared
to DSC-MRI perfusion using Dotarem® at 0.1 mmol/kg in terms of diagnostic quality of CBV perfusion
map (off-site assessment).

E.2.2

Secondary objectives of the trial

- To evaluate the diagnostic quality of CBV perfusion map for Elucirem® and Dotarem® (on-site
assessment)
- To compare the performance of DSC-MRI perfusion using Elucirem® at 0.05 mmol/kg to DSCMRI
using Dotarem® at 0.1 mmol/kg in differentiating glioma grade through the quantification
of the relative CBV (off-site assessment)
- To assess the reliability of the T2* signal intensity time curve in terms of confidence in diagnosis
in DSC-MRI perfusion using Elucirem® at 0.05 mmol/kg (on-site and off-site assessments)
- To expand the previously established safety profile of Elucirem® at 0.05 mmol/kg in terms of
incidence of adverse events

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Female or male adult patient (patient having reached legal majority age).
2. Patient with naive or recurrent primary glial tumor detected at a previous CT or MR imaging, and
scheduled for a follow-up contrast-enhanced MRI. Tumor grade (confirmed or highly suspected)
should be available in patients’ medical records.
3. Patient or, if the patient is unable to provide informed consent, the patient’s legally acceptable
representative, having read the information and having provided patient’s consent to participate in
writing by dating and signing the informed consent prior to any trial related procedure being
conducted.
4. Patient affiliated to national health insurance according to local regulatory requirements

E.4

Principal exclusion criteria

Patient presenting with one or more of the following non-inclusion criteria must not be included in the
trial:
1. 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).
2. Patient presenting with any contraindication to MRI examinations.
3. Post treatment patient presenting with pseudo-progression instead of tumor recurrency.
4. Patient presenting with severe renal insufficiency, defined as an estimated Glomerular Filtration
Rate (eGFR) < 30 mL/min/1.73 m² assessed within 1 week prior to contrast agent injection.
5. Patient having received any contrast agent (MRI or CT) within 3 days prior to IMP administration
or scheduled to receive any contrast agent within 24 hours after IMP administration.
6. Pregnant female patient (a female patient of childbearing potential or with amenorrhea for less than
12 months must have a negative pregnancy test within 1 day prior to trial MRI and must be using
medically approved contraception method* until the last trial visit).
7. 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.
8. Patient previously randomized in this trial.
9. 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.
10. 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.
11. Patient related to the investigator or any other trial staff or relative directly involved in the trial
conduct.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint of the trial is the proportion of patients presenting with images of excellent and good quality, according to off-site readers, in the Elucirem® and the Dotarem® arm.

E.5.1.1

Timepoint(s) of evaluation of this end point

After contrast injection

E.5.2

Secondary end point(s)

1) proportion of patients presenting with images of excellent and good quality, according to on-site reader,
in the Elucirem® and the Dotarem® arm.
2) Quantification of the relative cerebral blood volume and assessment of the T2* signal intensity time curve
3) Collection and assessment of all adverse events

E.5.2.1

Timepoint(s) of evaluation of this end point

The timepoint of secondary end point 1) and 2) is after contrast injection

Secondary endpoint 3) will be from ICF signature up to end of patient participation

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

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

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

For this study, only off-site readers will be blinded to the nature of the IMP injected.

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

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

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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

The trial is considered as completed once all the images collected for all the patients have been reviewed by all independent blinded readers and the histopathology results (if any) have been obtained. The patient’s participation is defined as the period from the screening visit (ICF signature) to the last visit.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

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

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

112

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

138

F.4.2.2

In the whole clinical trial

138

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2023-03-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-03-16

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2024-11-28

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