Discrimination of Benign and Malignant Human Tissue During Percutaneous Interventions Using Optical Spectroscopy Techniques
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pulmonary Coin Lesion
- Sponsor
- Philips Healthcare
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Differentiation between normal and malignant tissue
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Differentiation between normal and malignant tissue
Time Frame: Day 0
Statistical analysis of the difference between diffuse reflectance spectra obtained at normal and malignant measurement locations