Clinical trial · Interventional
Novel MRI Techniques for the Characterization and Treatment Assessment of High Grade Brain Lesions
Novel Multi-Parameter Mapping and Analysis Techniques for Characterization and Treatment Assessment of High Grade Brain Lesions
NCT04132843CI-TRIAL-00062283completedN/AClinicalTrials.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 studies different magnetic resonance imaging (MRI) techniques and their ability to provide clearer pictures of lesions in patients with high grade brain lesions. An MRI is a type of imaging scan. Using different MRI techniques to produce clearer images of the brain may help researchers learn about the features of brain lesions and the effects of chemotherapy and/or radiation therapy.
Conditions
Conditions (4)
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 Neoplasm | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Metastatic Malignant Neoplasm in the Brain | — | UNRESOLVED | — |
| Recurrent Malignant Brain Neoplasm | Malignant Brain Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gadobenate Dimeglumine | Drug | — | UNRESOLVED |
| Gadobutrol | Drug | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (MRI, gadobutrol, gadobenate dimeglumine)
- description
- Within 21 days before standard of care chemotherapy and/or radiation therapy, patients undergo an MRI scan for the first set of images. Patients then receive either gadobutrol or gadobenate dimeglumine IV and undergo an MRI for the second set of images. All MRI scans take a total of 60 minutes to complete. Patients then repeat the MRI scans 120 days after standard of care chemotherapy and/or radiation therapy.
- interventionNames
- Drug: Gadobenate Dimeglumine
- Drug: Gadobutrol
- Procedure: Magnetic Resonance Imaging
Primary outcomes (2)
- measure
- Differences in T2 spin parameters
- timeFrame
- Baseline
- description
- Will use 3-dimensional (3D) quantitative mapping to determine whether different in T2 spin parameters exist between the peritumoral area and normal brain in the contralateral hemisphere. If the data are normal, will calculate 95% confidence intervals around the mean paired difference in baseline T2 between the peritumoral and normal regions. If the data are not normally distributed, ordered statistics will be calculated, and bootstrapping will be used to estimate the 2.5th and 97.5th percentiles for the median.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least one enhancing lesion, aggregate of enhancing foci, and nonenhancing lesion measuring at least 1 cm in size and is suspected to be a high grade brain neoplasm * Patient is dispositioned to surgery, chemotherapy and/or radiation therapy * Patient is able to understand and give own consent to participate in the study Exclusion Criteria: * Contraindication to magnetic resonance imaging (MRI) as assessed by our standard of care magnetic resonance (MR) screening procedure, which includes implants or devices that are unsafe in the magnetic environment * Contraindication or history of allergy to Gadolinium-based (gadobutrol \[Gadovist\], gadobenate dimeglumine (Multihance\]) intravenous contrast * Verbal confirmation of pregnancy or a positive pregnancy test result in patient record * Prior partial (greater than 50%) or gross total resection of primary tumor * Prior chemotherapy or radiation treatment to brain
References
Publications (0)
Data not yet available
No reference posted for this study.