Clinical trial · Interventional
Use of Non-invasive Optical Analysis in Neurosurgery
Use of Non-invasive Optical Analysis in Neurosurgery - A Pilot Study
NCT04712214CI-TRIAL-00065932unknownN/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)
The present study aims to investigate the potential application of multispectral analysis, hyperspectral imaging, and fluorescence during neuro-oncological procedures, specifically during brain tumour debulking / resection. These optics techniques are entirely non-invasive and consist in camera with a filter to be linked to the standard microsurgical and endoscopic instruments used in theatre. The research procedure consists of images acquisition and data processing, with virtually no additional invasive procedures to be performed on patients.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | — | UNRESOLVED | — |
| Brain Tumour | Brain Neoplasm | ALIAS | 0.90 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| Meningioma | Meningioma | ONTOLOGY_EXACT | 0.90 |
| Schwannoma | Schwannoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intra-operative multispectral / hyperspectral analysis | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with brain tumours candidate for neurosurgery
- description
- Patients will be recruited following the inclusion criteria: any patient with a diagnosis of brain tumour, age ranging from 18 with no upper limit, who will agree to the operation and to take part of the present study, will be enrolled. During surgery, multispectral and/or hyper spectral acquisition of images from the surgical field will be performed. Each patient will have an average acquisition of 6 datasets. As each dataset will correspond to an image, this will be divided into many reading regions (from 10 to 20) for a total of approximatively 60 measurements per patient.
- interventionNames
- Device: Intra-operative multispectral / hyperspectral analysis
Primary outcomes (2)
- measure
- Analysis of spectroscopic signal reading between brain tissue and brain tumour
- timeFrame
- 3 years
- description
- Brain tissue and tumour tissue, the signals collected will be correlated both to the visual signal seen on normal operative field, a pre-set of brain images, and the signal seen on the peri-operative imaging (MRI scan).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Candidates for surgery due to a confirmed clinical and radiological diagnosis of cranial intrinsic or extrinsic tumour - any histological diagnosis confirming neuro-oncological disease, including primary and secondary disease * Agreed to take part to the present research protocol and signed proper informed consent form Exclusion Criteria: * Suspected differential diagnosis of pathological condition affecting central nervous system other than neuro-oncological disease - including demyelinating diseases, infections, brain traumas / haematomas, vascular or auto-immune diseases * Patients not capable to give consent - not in condition of understanding, processing and retaining information
References
Publications (4)
- BACKGROUNDBehrooz A, Waterman P, Vasquez KO, Meganck J, Peterson JD, Faqir I, Kempner J. Multispectral open-air intraoperative fluorescence imaging. Opt Lett. 2017 Aug 1;42(15):2964-2967. doi: 10.1364/OL.42.002964. PMID 28957220
- BACKGROUNDLu HD, Chen G, Cai J, Roe AW. Intrinsic signal optical imaging of visual brain activity: Tracking of fast cortical dynamics. Neuroimage. 2017 Mar 1;148:160-168. doi: 10.1016/j.neuroimage.2017.01.006. Epub 2017 Jan 4. PMID 28063974
- BACKGROUNDFawzy Y, Lam S, Zeng H. Rapid multispectral endoscopic imaging system for near real-time mapping of the mucosa blood supply in the lung. Biomed Opt Express. 2015 Jul 21;6(8):2980-90. doi: 10.1364/BOE.6.002980. eCollection 2015 Aug 1. PMID 26309761
- BACKGROUNDZhang Y, Wirkert SJ, Iszatt J, Kenngott H, Wagner M, Mayer B, Stock C, Clancy NT, Elson DS, Maier-Hein L. Tissue classification for laparoscopic image understanding based on multispectral texture analysis. J Med Imaging (Bellingham). 2017 Jan;4(1):015001. doi: 10.1117/1.JMI.4.1.015001. Epub 2017 Jan 25. PMID 28149926