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Investigation of application possibilities of optical spectroscopy within the field of oncology. Optical spectroscopy enables the possibility to specifically differentiate between different (human) tissues. The hypothesis is that incorporation of this technique into existing medical devices (e.g. biopsy needle) would enlarge the accuracy and reliability of these devices. The purpose is to improve and speed up the diagnostics and therapy of the malignancies.
Primary Objective:
In this observational study the investigators aim to evaluate whether optical spectroscopy can correctly diagnose malignant tissue in the existing clinical workflow of percutaneous interventions in lung, liver, and breast.
Secondary Objective:
During the measurement procedure, possible improvements of the measurement hardware will be recorded. Analysis of this documentation will provide information for possible alterations of hardware design for improved clinical applicability in the future. Special attention will be paid to observe how the procedure fits in the standard workflow of the radiologist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Histological biopsy procedures | Patients with a suspicious lesion in lung or liver or breast who are planned for a standard core biopsy procedure. And patients planned for percutaneous RFA (Radiofrequency Ablation) of colorectal liver metastasis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Core biopsy procedure | Procedure | Core biopsy of suspicious lesion in lung, liver, breast, or colorectal liver metastasis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Differentiation between normal and malignant tissue | Statistical analysis of the difference between diffuse reflectance spectra obtained at normal and malignant measurement locations | Day 0 |
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Inclusion Criteria:
General Exclusion criteria:
Breast Specific Exclusion criteria:
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Eligible patients are all patients, who are scheduled for a standard core biopsy of lung, liver or breast; or percutaneous RFA of liver in the Netherlands Cancer Institute (NKI-AvL), Amsterdam, The Netherlands. In the enrollment process the "patient informatie" will be used and the informed consent must be signed prior to the intervention.
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| Name | Affiliation | Role |
|---|---|---|
| Theo Ruers, MD | Nederlands Kanker Instituut/Antonie van leeuwenhoek Ziekenhuis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis | Amsterdam | North Holland | 1066 CX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30567584 | Derived | de Boer LL, Bydlon TM, van Duijnhoven F, Vranken Peeters MTFD, Loo CE, Winter-Warnars GAO, Sanders J, Sterenborg HJCM, Hendriks BHW, Ruers TJM. Towards the use of diffuse reflectance spectroscopy for real-time in vivo detection of breast cancer during surgery. J Transl Med. 2018 Dec 19;16(1):367. doi: 10.1186/s12967-018-1747-5. |
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| ID | Term |
|---|---|
| D003074 | Solitary Pulmonary Nodule |
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
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Biopsies are taken from the enrolled patients and these biopsies are send to the pathology department for histopathological analysis.
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |