Clinical trial · Interventional
Performance of Elucirem in DSC-MRI Perfusion of Brain Gliomas
Performance of Elucirem (Gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) Perfusion of Brain Gliomas Phase IIIb Clinical Trial
NCT06057168CI-TRIAL-00101917GDX-44-016completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial aimed to study the performance of Elucirem (gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) perfusion of brain gliomas.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor, Primary | Primary Brain Tumor | ONTOLOGY_EXACT | 0.98 |
| Brain Tumor, Recurrent | Brain Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dotarem | Drug | — | UNRESOLVED |
| Elucirem | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Elucirem
- description
- Patient underwent a DSC-MRI perfusion using Elucirem.
- interventionNames
- Drug: Elucirem
- type
- ACTIVE_COMPARATOR
- label
- Dotarem
- description
- Patient underwent a DSC-MRI perfusion using Dotarem.
- interventionNames
- Drug: Dotarem
Primary outcomes (1)
- measure
- Diagnostic Quality of Cerebral Blood Volume (CBV) Map of Dynamic Susceptibility Contrast MRI (DSC-MRI) Perfusion
- timeFrame
- From beginning to end of procedure for DSC-MRI perfusion using Elucirem or Dotarem
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.