Brain Tumor, PrimaryPhase 3GDX-44-016NCT06057168
Performance of Elucirem in DSC-MRI Perfusion of Brain Gliomas
A Phase 3 study testing Elucirem and Dotarem in people with Brain Tumor, Primary and Brain Tumor, Recurrent, run by Guerbet at 11 sites in 3 countries.
Trial summary
This trial aimed to study the performance of Elucirem (gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) perfusion of brain gliomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor, Primary, Brain Tumor, Recurrent
- What is being tested?
- Elucirem and Dotarem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 7 Sep 2023to 28 Nov 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male adult patient (patient having reached legal majority age).
- Patient with naive or recurrent primary glial tumor detected at a previous Computed Tomography (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.
- Patient or, if the patient is unable to provide informed consent, the patient's legally acceptable representative and/or impartial witness, 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.
- Patient affiliated to national health insurance according to local regulatory requirements.
Who cannot join
- Patient with known contra-indication(s) to the use or with known sensitivity to one of the products under investigation or to other Gadolinium-Based Contrast Agents (GBCA) (such as hypersensitivity, post-contrast acute kidney injury).
- Patient presenting with any contraindication to MRI examinations.
- Post treatment patient presenting with pseudo-progression instead of tumor recurrency.
- 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.
- Patient having received any contrast agent (for MRI or CT) within 3 days prior to IMP administration or scheduled to receive any contrast agent within 24 hours after IMP administration.
- 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).
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- 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.
- Patient previously randomized in this trial.
- 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.
- 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.
- Patient related to the investigator or any other trial staff or relative directly involved in the trial conduct.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
Hungary4 sites
Országos Idegtudományi Intézet - Neuroonkológiai és Intracraniá
Budapest
Semmelweis Egyetem - Neurologiai Klinika
Budapest
Debreceni Egyetem
Debrecen
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs
Italy4 sites
Ospedale Papa Giovanni XXIII
Bergamo
Ospedale San Raffaele- Neuroradiologia
Milan
IRCCS C.Mondino, Istituto Neurologico Nazionale, Fondazione
Pavia
Policlinico Universitario Agostino Gemelli
Roma
Poland3 sites
Uniwersyteckie Centrum Kliniczne w Gdansku
Gdansk
Szpital Specjalistyczny im.L.Rydygiera
Krakow
Independent Public Teaching Hospital no 1 Department of Interventional Radiology and Diagnostic Imaging
Lublin
About this study
Official title: Performance of Elucirem (Gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) Perfusion of Brain Gliomas Phase IIIb Clinical Trial
This trial aimed to study the performance of Elucirem (gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) perfusion of brain gliomas.
Read the detailed description
The trial was designed as a prospective, multi-center, randomized, controlled and parallel group comparison.
This study aimed to enrol 138 patients in Italy, Poland and Hungary.
During the course of the trial, patient underwent a DSC-MRI perfusion using Elucirem or Dotarem. A safety visit was performed 1 day after the MRI visit. Confirmation of tumor grade diagnosis, if available, was collected up to 30 days after visit 2. Primary end point was assessed by independent off-site blinded readers.
- Conditions
- Brain Tumor, Primary, Brain Tumor, Recurrent
- Being tested
- Elucirem, Dotarem
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EluciremDrug
Also called gadopiclenol
Intravenous administration
DotaremDrug
Also called gadoterate meglumine, gadoteric acid
Intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Elucirem | Experimental | Patient underwent a DSC-MRI perfusion using Elucirem. Receives: Drug: Elucirem |
| Dotarem | Active comparator | Patient underwent a DSC-MRI perfusion using Dotarem. Receives: Drug: Dotarem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Quality of Cerebral Blood Volume (CBV) Map of Dynamic Susceptibility Contrast MRI (DSC-MRI) Perfusion
Diagnostic quality of the CBV map obtained from DSC-MRI perfusion for each patient was assessed by the two off-site blinded readers using the following scale (poor, fair, good or excellent) and by a consensus in case of discordance between the two readers. The proportion of patients with "excellent" or "good" diagnostic quality images of Elucirem group was compared to that of Dotarem group. 124 patients (60 with Elucirem and 64 with Dotarem) who had diagnostic CBV map and without major protocol deviation were included in the per-protocol primary analysis.
Measured: From beginning to end of procedure for DSC-MRI perfusion using Elucirem or Dotarem
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start7 Sep 2023
- Primary completion28 Nov 2024
- Study completion28 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brain Tumor, PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guerbet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frantz Hebert, Study director, Guerbet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057168
- Sponsor's protocol ID
- GDX-44-016
- Acronym
- GDX-44-016
- Status last verified
- Nov 2025
- First submitted
- 11 Sep 2023
- Last updated
- 29 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Elucirem (Gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) Perfusion of Brain Gliomas Phase IIIb Clinical Trial
- ClinicalTrials.gov ID
- NCT06057168
- Acronym / sponsor ID
- GDX-44-016 / GDX-44-016
- Conditions
- Brain Tumor, Primary, Brain Tumor, Recurrent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- GuerbetIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 28 Nov 2024 (actual)
- Study completion
- 28 Nov 2024 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Posted 29 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial aimed to study the performance of Elucirem (gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) perfusion of brain gliomas.
Detailed description
The trial was designed as a prospective, multi-center, randomized, controlled and parallel group comparison.
This study aimed to enrol 138 patients in Italy, Poland and Hungary.
During the course of the trial, patient underwent a DSC-MRI perfusion using Elucirem or Dotarem. A safety visit was performed 1 day after the MRI visit. Confirmation of tumor grade diagnosis, if available, was collected up to 30 days after visit 2. Primary end point was assessed by independent off-site blinded readers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elucirem | Experimental | Drug: EluciremPatient underwent a DSC-MRI perfusion using Elucirem. |
| Dotarem | Active comparator | Drug: DotaremPatient underwent a DSC-MRI perfusion using Dotarem. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female or male adult patient (patient having reached legal majority age).
- Patient with naive or recurrent primary glial tumor detected at a previous Computed Tomography (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.
- Patient or, if the patient is unable to provide informed consent, the patient's legally acceptable representative and/or impartial witness, 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.
- Patient affiliated to national health insurance according to local regulatory requirements.
Key exclusion criteria (11 listed)
- Patient with known contra-indication(s) to the use or with known sensitivity to one of the products under investigation or to other Gadolinium-Based Contrast Agents (GBCA) (such as hypersensitivity, post-contrast acute kidney injury).
- Patient presenting with any contraindication to MRI examinations.
- Post treatment patient presenting with pseudo-progression instead of tumor recurrency.
- 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.
- Patient having received any contrast agent (for MRI or CT) within 3 days prior to IMP administration or scheduled to receive any contrast agent within 24 hours after IMP administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EluciremAlso: gadopiclenolIntravenous administration | Drug | Elucirem |
| DotaremAlso: gadoterate meglumine, gadoteric acidIntravenous administration | Drug | Dotarem |
Primary outcome
Diagnostic Quality of Cerebral Blood Volume (CBV) Map of Dynamic Susceptibility Contrast MRI (DSC-MRI) Perfusion
Time frame: From beginning to end of procedure for DSC-MRI perfusion using Elucirem or Dotarem
Diagnostic quality of the CBV map obtained from DSC-MRI perfusion for each patient was assessed by the two off-site blinded readers using the following scale (poor, fair, good or excellent) and by a consensus in case of discordance between the two readers. The proportion of patients with "excellent" or "good" diagnostic quality images of Elucirem group was compared to that of Dotarem group. 124 patients (60 with Elucirem and 64 with Dotarem) who had diagnostic CBV map and without major protocol deviation were included in the per-protocol primary analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frantz Hebert study director
Guerbet
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Elucirem and Dotarem in people with Brain Tumor, Primary and Brain Tumor, Recurrent, run by Guerbet at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Hungary, Italy, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Quality of Cerebral Blood Volume (CBV) Map of Dynamic Susceptibility Contrast MRI (DSC-MRI) Perfusion (time frame: From beginning to end of procedure for DSC-MRI perfusion using Elucirem or Dotarem). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.