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Observational study into specific in vivo human discrimination between benign and malignant tissue using a combination of Diffuse Reflectance and Fluorescence spectroscopy

Observational study into specific in vivo human discrimination between benign and malignant tissue using a combination of Diffuse Reflectance and Fluorescence spectroscopy - Discrimination of benign and malignant tissue using optical spectroscopy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON38249
Enrollment
113
Registered
2010-09-24
Start date
2011-02-01
Completion date
Unknown
Last updated
2024-08-12

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 proven malignant lesion of breast, lung or liver or benign fibroadenoma of the breast 2. In case of breast malignancy; patients are scheduled for total or partial resection of the breast 3. In case of lung malignancy; patients are scheduled for local resection, lobectomy or pneumonectomy during an *open* thoracic procedure 4. In case of liver malignancy; patients are scheduled for local resection or hemi-hepatectomy 5. Patients undergoing RFA for colorectal liver metastases and in whom the RFA-needle trjact will be entirely ablated 6. Written informed consent 7. Patients >= 18 years old

Exclusion criteria

Exclusion criteria: 1. Patients with no proof of residual malignant disease after neo-adjuvant therapy by follow-up radiological analysis before operation 2. Patients with suspected sensitivity to light; e.g. patients who have had photodynamic therapy

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 content within the tissue. 3. Pathology parameters: histology characteristics of the tissue, tumor grade, percentage necrosis The analysis of the optical spectroscopy 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 locations where the optical spectroscopy spectra have been collected correspond to the confirmation images by ultrasound and definite results from pathology. Meaning that the present study should succesfully acquire diffuse and fluorescence spectra in breast , liver and lung tissue discriminating normal tissue from malignant tissue.

Secondary

MeasureTime frame
During the surgery procedure possibilities and inabilities 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. To evaluate whether spectroscopy can assess the completeness of tumor ablation, additional optical spectroscopy measurements will be performed before, during and after RFA ablation.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)