Clinical trial · Interventional
Multi-site Validation and Application of a Consensus DSC-MRI Protocol
Multi-site Validation and Application of a Consensus Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) Protocol
NCT03401866CI-TRIAL-00031199unknownN/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 clinical trial is to validate and demonstrate the clinical usefulness of a protocol for Magnetic Resonance Imaging (MRI) in people with high grade glioma brain tumors.
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 |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
| Gliosarcoma | Gliosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DSC-MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- DSC-MRI scan
- description
- All subjects will receive a double dose injection protocol that will be split into multiple doses for sequential DSC-MRI scans.
- interventionNames
- Diagnostic Test: DSC-MRI
Primary outcomes (1)
- measure
- Histologic measures of tumor fraction
- timeFrame
- 1 day
- description
- Apply fractional tumor burden (FTB) rCBV thresholding methods to quantify recurrent tumor burden and compare this against histopathologic tumor burden from corresponding surgical specimens.
Secondary outcomes (2)
- measure
- Determine the repeatability of rCBV measured with the consensus DSC-MRI protocol.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven intracranial glioblastoma or gliosarcoma at initial surgery * Patient is currently being treated with standard first-line therapy for glioblastoma/gliosarcoma * Karnofsky performance status ≥ 70 * Age ≥ 18 years * Women must not be pregnant or breast-feeding as gadolinium enhanced MRI is contra-indicated * Progressive contrast enhancement (\> 25% increase in contrast enhancing volume compared to nadir, not corresponding to a region of peri-operative infarct seen on immediate post-op MRI) identified on routine surveillance MRI, with plan for surgical biopsy/resection. Measurable enhancement is defined as two perpendicular in-plane diameters of at least 10 mm and at least 10 mm in the 3rd orthogonal direction. This must be the patient's initial recurrence. * Intratumoral hemorrhage (acute, subacute, or chronic) as seen on hemosiderin-sensitive (gradient-echo) MRI may preclude patient inclusion because of anticipated limited evaluation due to magnetic susceptibility artifact on the heavily T2\*-weighted DSC-MRI images. If the region of enhancing tumor not affected by blooming artifact on the hemosiderin-sensitive images does not meet the 10 x 10 x 10 mm "measurable enhancement" threshold specified elsewhere, the patient is ineligible. * Patients must be able to tolerate brain MRI scans with dynamic intravenous gadolinium-based contrast agent injections * No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); * Weight compatible with limits imposed by the MRI scanner table. Exclusion Criteria: * Does not meet inclusion criteria
References
Publications (0)
Data not yet available
No reference posted for this study.