Clinical trial · Interventional
IRDye800CW-BBN PET-NIRF Imaging Guiding Surgery in Patients With Glioblastoma
PET-NIRF Dual Modality Imaging Guiding Surgery in Patients With Glioblastoma
- 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 an open-label positron emission tomography/near infrared (PET/NIRF) study to investigate the imaging navigation performance and evaluation efficacy of dual modality imaging probe 68Ga-BBN-IRDye800CW in glioblastoma (GBM) patients. A single dose of 40μg/111-148 Mega-Becquerel (MBq) and 1.0 mg/ml 68Ga-BBN-IRDye800CW will be injected intravenously before the operation and intraoperative respectively. Visual and semiquantitative method will be used to assess the PET images and real-time margins localization for surgical navigation.
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 |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-BBN-IRDye800CW | Drug | — | UNRESOLVED |
| PET/NIRF | Device | — | UNRESOLVED |
| PET/NIR fluorescent imaging-guided surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-BBN-IRDye800CW PET/NIRF
- description
- The patients were injected with 40μg/111-148 Mega-Becquerel (MBq) 68Ga-BBN-IRDye800CW in one dose intravenously and then underwent PET scan 30 min later before the operation and intraoperative 1.0 mg/ml BBN-IRDye800CW injected intravenously for near-infrared (NIR) fluorescent imaging-guided surgery.
- interventionNames
- Drug: 68Ga-BBN-IRDye800CW
- Device: PET/NIRF
- Procedure: PET/NIR fluorescent imaging-guided surgery
Primary outcomes (2)
- measure
- Standardized uptake value of 68Ga-BBN-IRDye800CW in PET imaging of GBM
- timeFrame
- 1 year
- description
- The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in GBM will be measured.
- measure
- Margin assessment of positive tumors in NIRF fluorescent-guided surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Must be able to provide a written informed consent * MRI imaging and/or pathological evidence of Newly Diagnosed or recurrence GBM Exclusion Criteria: * Consisted of conditions of mental illness * Severe liver or kidney disease with serum creatinine \> 3.0 mg/dl (270 μΜ) * Any hepatic enzyme level 5 times or more than normal upper limit * Severe allergy or hypersensitivity to IV radiographic contrast * Claustrophobia to accept the PET/CT scanning * Pregnancy or breast feeding
References
Publications (0)
Data not yet available