Breast Cancer Clinical Trial
Official title:
Discrimination of Benign and Malignant Human Tissue During Percutaneous Interventions Using Optical Spectroscopy Techniques
Verified date | April 2016 |
Source | Philips Healthcare |
Contact | n/a |
Is FDA regulated | No |
Health authority | Netherlands: Medical Ethics Review Committee (METC) |
Study type | Observational |
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.
Status | Completed |
Enrollment | 104 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Netherlands | Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis | Amsterdam | Noord-Holland |
Lead Sponsor | Collaborator |
---|---|
Philips Healthcare |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Differentiation between normal and malignant tissue | Statistical analysis of the difference between diffuse reflectance spectra obtained at normal and malignant measurement locations | Day 0 | No |
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