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Performance of Elucirem® in DSC-MRI Perfusion of Brain Gliomas (GDX-44-016)

Primary Purpose

Brain Tumor, Primary, Brain Tumor, Recurrent

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Elucirem
Dotarem
Sponsored by
Guerbet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Tumor, Primary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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). 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.

Sites / Locations

  • Országos Idegtudományi Intézet - Neuroonkológiai és Intracraniá
  • Semmelweis Egyetem - Neurologiai Klinika
  • Debreceni Egyetem
  • Pecsi Tudomanyegyetem Klinikai Kozpont
  • Ospedale Papa Giovanni XXIII
  • Ospedale San Raffaele- Neuroradiologia
  • IRCCS C.Mondino, Istituto Neurologico Nazionale, FondazioneRecruiting
  • Policlinico Universitario Agostino Gemelli
  • Uniwersyteckie Centrum Kliniczne w Gdansku
  • Szpital Specjalistyczny im.L.Rydygiera
  • Independent Public Teaching Hospital no 1 Department of Interventional Radiology and Diagnostic Imaging

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Elucirem®

Dotarem®

Arm Description

Patient will undergo a DSC-MRI perfusion using Elucirem®

Patient will undergo a DSC-MRI perfusion using Dotarem®

Outcomes

Primary Outcome Measures

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 Cerebral Blood Volume perfusion map
Diagnostic quality of the CBV map will be assessed by off-site readers using a 4-point scale with the grades: poor, fair, good or excellent

Secondary Outcome Measures

To evaluate the diagnostic quality of CBV perfusion map for Elucirem® and Dotarem® (on-site assessment)
Diagnostic quality of the CBV map will be assessed by on-site readers using the same 4-point scale as the one used for primary evaluation criterion
To compare the performance of DSC-MRI perfusion using Elucirem® at 0.05 mmol/kg to DSC-MRI using Dotarem® at 0.1 mmol/kg in differentiating glioma grade through the quantification of the relative CBV (rCBV) (off-site assessment)
The rCBV will be calculated on the CBV perfusion maps generated for each DSC-MRI perfusion. The regions of interest (ROIs) will be placed by off-site readers on the tumor for providing tumor CBV and also on normal tissue (contralateral normal-appearing white matter) for providing referenced CBV.
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)
T2* signal intensity time curve will be visually assessed by on-site and off-site readers for the reliability of the curve in providing sufficient information for diagnosis purpose. The Full-Width at Half-Maximum (FWHM) and the maximum signal drop will be measured by off-site readers only.
To expand the previously established safety profile of Elucirem® at 0.05 mmol/kg in terms of incidence of adverse events
Adverse events, serious or not, related to IMP or not, that occur from the beginning of patient's participation in the trial (Informed Consent Form signature) until the end of the participation.

Full Information

First Posted
September 11, 2023
Last Updated
September 25, 2023
Sponsor
Guerbet
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1. Study Identification

Unique Protocol Identification Number
NCT06057168
Brief Title
Performance of Elucirem® in DSC-MRI Perfusion of Brain Gliomas
Acronym
GDX-44-016
Official Title
Performance of Elucirem® (Gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) Perfusion of Brain Gliomas Phase IIIb Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2023 (Actual)
Primary Completion Date
April 29, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guerbet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial aims to study the performance of Elucirem® (gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) perfusion of brain gliomas.
Detailed Description
The trial is designed as a prospective, multi-center, randomized, controlled and parallel group comparison. This study aims to enrol 138 patients in Italy, Poland and Hungary. During the course of the trial, patient will undergo a DSC-MRI perfusion using Elucirem® or Dotarem®. A safety visit will be performed 1 day after the MRI visit. Confirmation of tumor grade diagnosis, if available, will be collected up to 30 days after visit 2. Primary end point will be assessed by independent off-site blinded readers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Primary, Brain Tumor, Recurrent

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Elucirem®
Arm Type
Experimental
Arm Description
Patient will undergo a DSC-MRI perfusion using Elucirem®
Arm Title
Dotarem®
Arm Type
Active Comparator
Arm Description
Patient will undergo a DSC-MRI perfusion using Dotarem®
Intervention Type
Drug
Intervention Name(s)
Elucirem
Other Intervention Name(s)
gadopiclenol
Intervention Description
Intravenous administration
Intervention Type
Drug
Intervention Name(s)
Dotarem
Other Intervention Name(s)
gadoterate meglumine, gadoteric acid
Intervention Description
Intravenous administration
Primary Outcome Measure Information:
Title
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 Cerebral Blood Volume perfusion map
Description
Diagnostic quality of the CBV map will be assessed by off-site readers using a 4-point scale with the grades: poor, fair, good or excellent
Time Frame
Evaluation is performed within 6 months after obtaining MRI scan and CBV map
Secondary Outcome Measure Information:
Title
To evaluate the diagnostic quality of CBV perfusion map for Elucirem® and Dotarem® (on-site assessment)
Description
Diagnostic quality of the CBV map will be assessed by on-site readers using the same 4-point scale as the one used for primary evaluation criterion
Time Frame
Evaluation is performed within 1 month after obtaining MRI scan and CBV map
Title
To compare the performance of DSC-MRI perfusion using Elucirem® at 0.05 mmol/kg to DSC-MRI using Dotarem® at 0.1 mmol/kg in differentiating glioma grade through the quantification of the relative CBV (rCBV) (off-site assessment)
Description
The rCBV will be calculated on the CBV perfusion maps generated for each DSC-MRI perfusion. The regions of interest (ROIs) will be placed by off-site readers on the tumor for providing tumor CBV and also on normal tissue (contralateral normal-appearing white matter) for providing referenced CBV.
Time Frame
Evaluation is performed within 6 months after obtaining MRI scan and CBV map
Title
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)
Description
T2* signal intensity time curve will be visually assessed by on-site and off-site readers for the reliability of the curve in providing sufficient information for diagnosis purpose. The Full-Width at Half-Maximum (FWHM) and the maximum signal drop will be measured by off-site readers only.
Time Frame
Evaluation is performed within 6 months after obtaining MRI scan and CBV map
Title
To expand the previously established safety profile of Elucirem® at 0.05 mmol/kg in terms of incidence of adverse events
Description
Adverse events, serious or not, related to IMP or not, that occur from the beginning of patient's participation in the trial (Informed Consent Form signature) until the end of the participation.
Time Frame
Evaluation is performed from the beginning of patient's participation in the trial (Informed Consent Form signature) until the end of the participation (maximum 37 days).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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). 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie Rollin, PhD
Phone
+331 45 91 50 00
Email
sophie.rollin@guerbet.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Hao, MD
Organizational Affiliation
Guerbet
Official's Role
Study Chair
Facility Information:
Facility Name
Országos Idegtudományi Intézet - Neuroonkológiai és Intracraniá
City
Budapest
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Attila Bago, MD
Facility Name
Semmelweis Egyetem - Neurologiai Klinika
City
Budapest
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Bereczki, MD
Facility Name
Debreceni Egyetem
City
Debrecen
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gábor Hutóczki, MD
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont
City
Pécs
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Attila Schwarc, MD
Facility Name
Ospedale Papa Giovanni XXIII
City
Bergamo
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simonetta Gerevini, MD
Facility Name
Ospedale San Raffaele- Neuroradiologia
City
Milano
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicoletta Anzalone, MD
Facility Name
IRCCS C.Mondino, Istituto Neurologico Nazionale, Fondazione
City
Pavia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Pichiecchio, MD
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simona Gaudino, MD
Facility Name
Uniwersyteckie Centrum Kliniczne w Gdansku
City
Gdańsk
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katarzyna Dziadziuszko, MD
Facility Name
Szpital Specjalistyczny im.L.Rydygiera
City
Kraków
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ewa Janczyk, MD
Facility Name
Independent Public Teaching Hospital no 1 Department of Interventional Radiology and Diagnostic Imaging
City
Lublin
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radosław Pietura, MD

12. IPD Sharing Statement

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Performance of Elucirem® in DSC-MRI Perfusion of Brain Gliomas

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