Optical Detection of Malignancy During Percutaneous Interventions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Discrimination of Benign and Malignant Human Tissue During Percutaneous Interventions Using Optical Spectroscopy Techniques

Conditions
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Pulmonary Coin Lesion, Colon Cancer Liver Metastasis, Breast Cancer

Intervention / Treatment
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* Procedure: Core biopsy procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a suspicious lesion in lung or liver who are scheduled for a standard core biopsy procedure Patient planned for percutaneous RFA of colorectal liver metastasis Written informed consent Patients ≥ 18 years old Breast patients with a BIRADS score 4 or 5 General Exclusion criteria: Patients who have higher risk of bleeding Patients with suspected sensitivity to light; e.g. patients who have had photodynamic therapy Breast Specific Exclusion criteria: Patients who have a history of breast cancer and/or who have received prior chemotherapy, endocrine therapy, or radiation therapy Patients who have breast implants Patients needing a stereotactic breast biopsy (i.e. non palpable-, ultrasound opaque lesions)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Histological biopsy procedures<br>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 | Procedure: Core biopsy procedure<br>* Core biopsy of suspicious lesion in lung, liver, breast, or colorectal liver metastasis.<br>* Other names: Standard biopsy procedure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spectroscopy, tumour, biopsy, malignancy