Clinical trial · Observational
Loupe-Based Intraoperative Fluorescence Imaging
Loupe-Based Intraoperative Fluorescence Imaging for the Guidance of Brain Tumor Surgery
- 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)
Glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA) are the most common primary malignant brain tumors. Survival of patients with these brain tumors is directly related to the extent of resection. Consequently, a great deal of effort has been directed at developing techniques and technologies that allow more extensive, safe resections. This study will test a loupe-based wearable device in the clinical setting and compare its accuracy with a large operative microscope to identify tumor tissues. Postoperative histopathological analysis on tumor tissues will be used as gold standards for comparison. The outcome from this study will be a low-cost, miniaturized, easy-to-operate, loupe-based fluorescence imaging device for intraoperative guidance of brain tumor resection with the same level of accuracy as the large microscope.
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 |
|---|---|---|---|
| Anaplastic Astrocytoma | Anaplastic Astrocytoma | CURATED_BROADER | 0.80 |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Positive Predictive Value (PPV)
- timeFrame
- 1 day
- description
- The proportion of samples that are histologically confirmed as tumor-positive among all fluorescent samples will be calculated.
- measure
- Negative Predictive Value (NPV)
- timeFrame
- 1 day
- description
- The proportion of samples that are histologically confirmed as tumor-negative among all fluorescent samples will be calculated.
Secondary outcomes (1)
- measure
- Residual Tumor
- timeFrame
- 1 day
- description
- The proportion of positive results among all tumors with residual as well as the proportion of negative results among tumors without residual will be calculated relative to post-operative histopathological analysis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * adults with brain malignant gliomas undergoing resection * at least 18 years of age * able to understand the consent Exclusion Criteria: * pregnant women * under 18 years of age * patients undergoing emergency surgery * inability to give consent due to dysphagia or language barrier
References
Publications (0)
Data not yet available