Optical Detection of Peripheral Nerve Bundles During Surgery

Study Overview
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Brief Summary
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Investigation of application possibilities of optical spectroscopy within the field of surgical resection procedures to spare nerve tissue. 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. medical blade) would enlarge the accuracy and reliability of these devices. Sparing of nerve bundles during surgery can lead to decreased postoperative morbidity rates.

Detailed Description
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The aim of this pilot study is to prove that an investigational optical spectroscopy system can provide accurate identification of nerve tissue during surgery. Primary Objective: The goal of this pilot study is to evaluate whether optical spectroscopy is able to differentiate between nerve tissue and surrounding tissue. Secondary Objective: During the measurement procedure, possible improvements of the measurement hardware will be recorded and the handling of the optical spectroscopy system during surgery will be evaluated.

Official Title
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In Vivo Identification of Peripheral Nerve Bundles During Surgery Using Optical Spectroscopy Techniques - a Pilot Study

Conditions
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Malignant Lymphoma of Lymph Nodes of Inguinal Region, Malignant Lymphoma of Lymph Nodes of Axillary, Malignant Lymphoma of Lymph Nodes of the Cervix, Carcinoma of Parotid Gland, Colon Rectal Cancer Tubulovillous Adenocarcinoma, Tumor of Soft Tissue of Head, Face and Neck

Intervention / Treatment
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* Procedure: Surgical resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy , patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour. Patients that have provided a signed informed consent Patients ≥ 18 years old Exclusion Criteria: • Patients with suspected sensitivity to light; e.g. patients who have had photodynamic therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical resections<br>Patients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy, patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour. | Procedure: Surgical resection<br>* Patients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy , patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour.<br>* Other names: soft tumor resection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differentiation between nerve tissue and its surrounding tissue | Statistical analysis of the difference between diffuse reflectance spectra obtained at nerve tissue and its surrounding tissue measurement locations | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spectroscopy, nerve, muscle, fat