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Discrimination of benign and malignant human tissue during percutaneous interventions using optical spectroscopy techniques

Discrimination of benign and malignant human tissue during percutaneous interventions using optical spectroscopy techniques - Optical detection of malignancy during percutaneous interventions

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41588
Enrollment
106
Registered
2012-08-21
Start date
2012-10-08
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Cancer Malignancy

Interventions

None listed

Sponsors

Philips Research
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Patients with a suspicious lesion in breast, lung or liver who are scheduled for a standard core biopsy procedure 2) Patient planned for percutaneous RFA of colorectal liver metastasis 3) Written informed consent 4) Patients >= 18 years old 5) Breast patients with a BIRADS score 4 or 5

Exclusion criteria

Exclusion criteria: 1) Patients who have high risk of bleeding 2) Patients with suspected sensitivity to light; e.g. patients who have had photodynamic therapy 3) Patients who have a history of breast cancer and/or who have received prior chemotherapy, endocrine therapy, or radiation therapy 4) Patients who have breast implants 5) Patients needing a stereotactic breast biopsy (i.e. non palpable-, ultrasound opaque lesions)

Design outcomes

Primary

MeasureTime frame
Several optical spectroscopy parameters of the targeted tissues will be analysed, specified and then compared to histopathological analysis: 1) Diffuse reflectance parameters: Oxyhaemoglobin saturation, total haemoglobin content, water and fat content within the tissue as well as 2 scatter coefficients of the tissue. 2) Fluorescence parameters: Collagen, elastin, NADH and Porhyrin content within the tissue. 3) Pathology parameters: histology characteristics of the tissue, tumor grade, percentage necrosis The analysis of the different reflectance and fluorescence parameters will result in a specific tissue fingerprint allowing optical tissue characterization, discriminating malignant tissue from normal or benign tissue. These results will be compared to standard histopathological examination. Primary endpoint: To confirm that the results of the diffuse reflectance and fluorescence spectra correspond to the results from pathology. Meaning that the present study should prove that optical spectra can provide information that can be used for better localization of a biopsy needle or RFA-probe in the future.

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)