Clinical trial · Interventional
Second Window Indocyanine Green for All Nervous System Tumors
Intraoperative Molecular Imaging of Central Nervous System Tumors Using Same Day Second Window Imaging With Indocyanine Green (TumorGlow™ - CNS)
NCT05746104CI-TRIAL-00101433enrolling by invitationPhase 1ClinicalTrials.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)
The study is being conducted to determine if a same-day, low-dose intravenous (into a vein) injection of indocyanine green (ICG) (FDA-approved dye) being detected by using an imaging system can be a useful tool in identifying and differentiating tumor tissue from normal tissues.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nervous System Tumor | Nervous System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Administration of Indocyanine Green (ICG) and Visualization of Tumor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SWIG Arm
- description
- This is the only arm for the study and will be experimental. All patients will receive the appropriate dosage of the study drug, which will then be used for visualization of the tumor intraoperatively.
- interventionNames
- Drug: Administration of Indocyanine Green (ICG) and Visualization of Tumor
Primary outcomes (3)
- measure
- Tumor NIR Signal Compared to Background Brain Normal Signal (SBR)
- timeFrame
- Surgery
- description
- SBR analysis will be stratified by histology, and the dosing and timing flowchart will be used to achieve optimal SBR.
- measure
- NIR Efficiency
- timeFrame
- Surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult patients 18 years of age and older 2. Patients presenting with a nervous system tumor presumed to be resectable and at risk for local recurrence on pre-operative assessment 3. Good operative candidates, as determined by the treating physician and multidisciplinary team 4. Subjects capable of giving informed consent Exclusion Criteria: 1. Pregnant women, as determined by urinary or serum beta hCG within 48 hours of surgery 2. Subjects with a history of iodide allergies 3. Vulnerable patient populations 4. Patients unable to participate in the consent process 5. Patients with history of uncontrolled HTN (requiring ER admission or ≥ 3 BP medications)
References
Publications (0)
Data not yet available
No reference posted for this study.