New contrast agent shows promise for brain tumor MRI scans
NCT ID NCT06057168
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed Phase 3 trial tested whether Elucirem (gadopiclenol) provides better MRI images of brain gliomas compared to the standard contrast agent Dotarem. 138 adults with primary or recurrent brain tumors received one of the two agents during DSC-MRI perfusion scans. The main goal was to compare the quality of blood flow maps, rated as poor, fair, good, or excellent by independent readers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Elucirem (gadopiclenol)
- What this could lead to
- If successful, Elucirem could become a better contrast agent for MRI scans of brain tumors, helping doctors see tumor blood flow more clearly.
- What could go wrong
- This is a completed Phase 3 trial, but it only compares image quality, not patient outcomes. The new agent may not be significantly better than the current standard.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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138 people
The number who actually took part.
- Started
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Sep 2023
- Finished
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Nov 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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. 3. 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. 4. Patient affiliated to national health insurance according to local regulatory requirements. Exclusion Criteria: 1. 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). 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 (for 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Debreceni Egyetem
Debrecen, Hungary
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IRCCS C.Mondino, Istituto Neurologico Nazionale, Fondazione
Pavia, Italy
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Independent Public Teaching Hospital no 1 Department of Interventional Radiology and Diagnostic Imaging
Lublin, Poland
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Országos Idegtudományi Intézet - Neuroonkológiai és Intracraniá
Budapest, Hungary
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Ospedale Papa Giovanni XXIII
Bergamo, Italy
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Ospedale San Raffaele- Neuroradiologia
Milan, Italy
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Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, Hungary
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Policlinico Universitario Agostino Gemelli
Roma, Italy
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Semmelweis Egyetem - Neurologiai Klinika
Budapest, Hungary
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Szpital Specjalistyczny im.L.Rydygiera
Krakow, Poland
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Uniwersyteckie Centrum Kliniczne w Gdansku
Gdansk, Poland
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