Brain Tumor, Primary, Brain Tumor, Recurrent
Conditions
Brief summary
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.
Interventions
DRUGElucirem
Intravenous administration
DRUGDotarem
Intravenous administration
Sponsors
Guerbet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Quality of Cerebral Blood Volume (CBV) Map of Dynamic Susceptibility Contrast MRI (DSC-MRI) Perfusion | 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. |
Countries
Hungary, Italy, Poland
Contacts
STUDY_DIRECTORFrantz Hebert
Guerbet
Participant flow
Recruitment details
A total of 141 patients were screened in 10 centers from three countries: 76 from four centers in Hungary, 48 from four centers in Italy and 17 from two centers in Poland.
Pre-assignment details
Out of the 141 screened patients, 3 patients were screen failed. Therefore, 138 patients were randomized in the trial with 69 in each arm. Out of them, 2 patients prematurely discontinued the study before the injection of contrast agent. The remaining 136 patients underwent MRI examination with injection of IMP: 67 with Elucirem and 69 with Dotarem. A total of 124 patients were included in the per-protocol primary analysis: 60 with Elucirem and 64 with Dotarem.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 18 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants |
| Age, Continuous | 54.8 years STANDARD_DEVIATION 14.42 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 68 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 69 |
| other Total, other adverse events | 3 / 67 | 2 / 69 |
| serious Total, serious adverse events | 0 / 67 | 0 / 69 |
Outcome results
None listed