Clinical trial · Interventional
Fluorescein vs. iMRI in Resection of Malignant High Grade Glioma
Fluorescein vs. Intraoperative MRI in the Resection of Malignant High Grade Glioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The investigators decided not to move forward with this study at this time.
Summary
Brief summary (as posted)
This study plans to learn more about if fluorescein with intraoperative Magnetic Resonance Imaging (MRI) is as good as intraoperative MRI (iMRI) alone in detecting the presence of tumor tissue during surgery. Both fluorescein and intraoperative MRI have been studied and routinely used to aid the neurosurgeon in distinguishing normal brain from tumor, helping the neurosurgeon to safely resect more tumor tissue during surgery. This study will enroll patients with malignant high grade glioma who are going to have a surgery to remove their brain tumor. For half of the patients, fluorescein and intraoperative MRI will be used together during surgery. For half of the patients, only intraoperative MRI will be used during surgery. iMRI is used as final verification of complete, safe resection in both arms.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Astrocytoma | Anaplastic Astrocytoma | CURATED_BROADER | 0.80 |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
| High Grade Malignant Neoplasm | High Grade Malignant Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorescein | Other | — | UNRESOLVED |
| intraoperative MRI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Flourescein plus intraoperative MRI
- interventionNames
- Other: fluorescein
- Other: intraoperative MRI
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- intraoperative MRI alone
- interventionNames
- Other: intraoperative MRI
Primary outcomes (1)
- measure
- Extent of resection
- timeFrame
- 36 hours
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Presents with presumed or pathologically proven enhancing primary or secondary high grade glioma for surgical resection * Eligible for gross total resection of enhancing component of tumor * Karnofsy performance status \>/= 70% Exclusion Criteria: * Presence of multi-focal disease * Disease that crosses the mid-line * History of adverse reaction to flourescein * Known ongoing pregnancy * Inability to grant consent * Contraindication to perform iMRI * Contraindication to flourescein
References
Publications (0)
Data not yet available