Endoscopic Optical Imaging for Precision Oncology Treatment Applied to Colorectal Tumours
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Evaluation of the sensitivity of Bevacizumab-IRDye800 to visualize tumour tissue compared to anti-VEGF antibodies by the means of fluorescence intensity measurements
研究概览
简要总结
The Institute of Image-Guided Surgery (IHU) of Strasbourg is a translational research Institute aiming to develop hybrid surgery techniques. The IHU-SPECTRA research unit, entirely dedicated to the development of fluorescence-guided surgery, was set up to test several innovations as part of a large-scale project (ELIOS: Endoscopic Luminescent Imaging for Precision Oncology Surgery), funded by the ARC Foundation for Cancer Research. The proposed research protocol is part of the ELIOS project and targets in particular colon tumours.
The Holy Grail in oncology surgery is the radical removal of cancer cells in order to reduce the rate of tumour recurrences and increase the tumour's free survival.
The administration of a tumour-specific antibody, which fluoresces in the Near-Infrared ranges and which could be univocally recognized at a tumour cellular level, could provide a rapid and accurate evaluation of radical tumour removal.
The University Medical Center Groningen (UMCG) has developed a fluorescent tracer coupling Bevacizumab (which targets the Vascular Endothelial Growth Factor = VEGF) with a fluorescent dye, the IRDye800. The initial human results are very promising and no adverse events linked to the fluorescent molecule have been reported.
In parallel, an alternative optical technique that does not require the use of a fluorophore, the Hyperspectral Imaging (HSI), is a relatively new method used in image-guided and precision surgery. The company Diaspective Vision GmbH (Pepelw, Germany) produces a HSI camera, the TIVITA system, enabling to obtain spectral information from the tissues. The main advantage of HSI over fluorescence imaging is in that it is a contrast-free imaging and intrinsically quantitative although it does not provide real-time videos.
Another innovative optical imaging technology available at the IHU is FF-OCT (Light-CT Scanner, LLTechSAS, Paris, France) which allows non-destructive and high-resolution optical biopsy without tissue treatment.
The working hypothesis is that molecular fluorescence enhanced-reality allows greater precision in the differentiation of tumour tissue and healthy tissue in patients with colorectal cancer compared to the immunohistochemistry conventionally used in anatomopathology.
In parallel, this technique will be compared to hyperspectral imaging (HSI TIVITA system) and optical imaging (FF-OCT system), two potentially advantageous methods for the detection of tumour tissue.
详细描述
The Institute of Image-Guided Surgery (IHU) of Strasbourg is a translational research Institute aiming to develop hybrid surgery techniques, less invasive and image-guided to improve the therapeutic results, in the emerging context of the precision medicine.
One of those expanding technique is fluorescence imaging that can guide the surgical procedure very accurately.
The IHU-SPECTRA research unit, entirely dedicated to the development of fluorescence-guided surgery, was set up at the IHU Strasbourg. Currently represented by a network of scientists from different fields and by industrial and academic partners in France and abroad, its short-term goals are mainly the implementation and evaluation in current clinical practice of the techniques already developed. In the long term, it is planned to test several innovations as part of a large-scale project (ELIOS: Endoscopic Luminescent Imaging for Precision Oncology Surgery), funded by the ARC Foundation for Cancer Research.
The proposed research protocol is part of the ELIOS project and targets in particular colon tumours.
The Holy Grail in oncology surgery is the radical removal of cancer cells in order to reduce the rate of tumour recurrences and increase the tumour's free survival. Tumour involvement at the resection margins is the most important predictor of tumour recurrence, leading to high recurrence rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman over 18 years old
- •Patient with colorectal cancer
- •Patient able to receive and understand information related to the study and to give written informed consent.
- •Patient affiliated to the French social security system
排除标准
- •Pregnant or lactating patient
- •Patient in exclusion period (determined by a previous or a current study)
- •Patient under guardianship or trusteeship
- •Patient under the protection of justice
研究组 & 干预措施
Fluorescence characterization
干预措施: Characterization of tumor tissue by fluorescence (Other)
结局指标
主要结局
Evaluation of the sensitivity of Bevacizumab-IRDye800 to visualize tumour tissue compared to anti-VEGF antibodies by the means of fluorescence intensity measurements
时间窗: 1 day
Correlation between the fluorescence signal intensity of Bevacizumab-IRDye800CW emitted by tumours and sensed by near-infrared imaging systems compared to VEGF expression levels in immunohistochemistry and histological diagnosis
Evaluation of the sensitivity of Bevacizumab-IRDye800 to visualize tumour tissue relative to surrounding healthy tissue by the means of fluorescence intensity measurements
时间窗: 1 day
Correlation between the fluorescence signal intensity of Bevacizumab-IRDye800CW emitted by tumours and sensed by near-infrared imaging systems compared to the fluorescence emitted by healthy tissue
次要结局
- Ability of HSI to determine the tumour stage from the serosal side(1 day)
- HSI's ability to identify the tumoural and healthy tissue from the mucosal side compared to the results provided by histopathology and immunohistochemistry (IHC).(1 day)
- Level of accuracy of fluorescence microscopy compared to ImmunoHistoChemistry(1 day)
- Ability of HSI to detect the tumour area on the serosal side after marking the margins of resection by the means of spectral signature characterization(1 day)
- Level of accuracy of resection of a fluorescence-guided tumour determined by the presence or absence of tumourous cells on resection margins by histological examination(1 day)
- Ability of Hyperspectral Imaging (HSI) to detect the tumour area on the serosal side before marking the margins of resection by the means of spectral signature characterization(1 day)
- Level of accuracy of Full-field optical coherence tomography (FF-OCT) by the means of a qualitative analysis(1 day)