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Optical Detection of Malignancy During Percutaneous Interventions

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01730365
Enrollment
104
Registered
2012-11-21
Start date
2012-10-31
Completion date
2015-12-31
Last updated
2016-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Colon Cancer Liver Metastasis, Pulmonary Coin Lesion

Keywords

spectroscopy, tumour, biopsy, malignancy

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.

Interventions

PROCEDURECore biopsy procedure

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

Sponsors

Philips Healthcare
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Differentiation between normal and malignant tissueDay 0Statistical analysis of the difference between diffuse reflectance spectra obtained at normal and malignant measurement locations

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026