Optical Detection of Malignancy During Percutaneous Interventions

Philips Healthcare104 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

104

Conditions

Pulmonary Coin Lesion Colon Cancer Liver Metastasis Breast Cancer

Interventions

Core biopsy procedurePROCEDURE

Core biopsy of suspicious lesion in lung, liver, breast, or colorectal liver metastasis.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis

Amsterdam, North Holland, Netherlands

Outcomes

Primary Outcomes

Differentiation between normal and malignant tissue

Statistical analysis of the difference between diffuse reflectance spectra obtained at normal and malignant measurement locations

Time frame: Day 0

Data from ClinicalTrials.gov

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