Clinical trial · Observational
Retrospective Study of MRI With MULTIHANCE at 0.10 and 0.05 mmol/Kg Dose in CNS Patients
A Parallel-Group Comparison of Two Doses Of Multihance (0.10 mmol/Kg and 0.05 mmol/Kg) When Used For Magnetic Resonance Imaging (MRI) of The Central Nervous System (CNS)
- 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 is a retrospective study to collect already existing data and images from patients ≥ 2 years of age who had MRI for CNS diseases with MultiHance administration at a standard 0.10 mmol/kg dose or the half dose of 0.05 mmol/kg. The MRI images of all included patients will be prospectively reviewed in a blinded read to compare the efficacy of the two doses.
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 |
|---|---|---|---|
| Central Nervous System Diseases | — | UNRESOLVED | — |
| Central Nervous System Neoplasms | Central Nervous System Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MultiHance | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group 1, 0.10 mmol/kg
- description
- For patients having received MULTIHANCE at a standard dose of 0.10 mmol/kg for their clinically indicated MRI examination.
- interventionNames
- Drug: MultiHance
- label
- Group 2, 0.05 mmol/kg
- description
- For patients having received MULTIHANCE at a dose of 0.05 mmol/kg for their clinically indicated MRI examination.
- interventionNames
- Drug: MultiHance
Primary outcomes (3)
- measure
- Non-inferiority in border delineation of lesions
- timeFrame
- 1 Day
- description
- To show non-inferiority of a 0.05 mmol/kg dose of MULTIHANCE as compared to 0.10 mmol/kg dose of MULTIHANCE, in patients undergoing contrast-enhanced MRI of the CNS in terms of lesion visualization based on pre-dose + post-dose: Border delineation of lesions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
Show eligibility criteria text
Inclusion Criteria: * Was at least 2 years of age at the time of the MRI with MULTIHANCE injection at the dose of either 0.1 or 0.05 mmol/kg (±20% in volume administered). * Has available demographic and safety data. * Belongs to one of these 4 sub-groups: 1. Had a documented known extra-axial lesion of the CNS and previously underwent MRI with a 1.5T magnet requiring an injection of 0.1 mmol/kg MULTIHANCE. 2. Had a documented known extra-axial lesion of the CNS and previously underwent MRI with a 1.5T magnet requiring an injection of 0.05 mmol/kg MULTIHANCE. 3. Had a documented known lesion of the CNS (including extra-axial) and previously underwent MRI with 3T magnet requiring an injection of 0.1 mmol/kg MULTIHANCE. 4. Had a documented known lesion of the CNS (including extra-axial) and previously underwent MRI with 3T magnet requiring an injection of 0.05 mmol/kg MULTIHANCE. * Have both pre- and post-dose T1 SE/FSE, and/or GRE, and T2 SE/FSE, and FLAIR MR Images (when available). * Has one of the two documented doses of MULTIHANCE (either 0.05 or 0.1 mmol/kg) administered for their MRI exam and/or the volume (mL) and weight of the patient available to be used to calculate the exact dose (mmol/kg) of MULTIHANCE that was administered. Exclusion Criteria: * Any patient who does not fulfill all of the inclusion criteria; * Any patient who has been previously entered into this study. Patients must be enrolled only once into the study. Working backward chronologically from date of the final Protocol, if a patient has already been enrolled and appears in the PACs System again due to an earlier MRI, this patient must be excluded from the study (i.e., only the first qualifying MRI working backward chronologically from the date of the final Protocol should be included into the study).
References
Publications (0)
Data not yet available