## Protocol Section
### Identification Module
**NCT ID:** NCT01731379

**Acronym:** NerveSpect

**Brief Title:** Optical Detection of Peripheral Nerve Bundles During Surgery

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

#### Organization Study ID Info
**ID:** NL 40893.031.12
#### Organization
**Class:** INDUSTRY
**Full Name:** Philips Healthcare
### Status Module
#### Completion Date
**Date:** 2015-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-11-03

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-11-02

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-01

**Type:** ACTUAL

#### Start Date
**Date:** 2012-12

**Status Verified Date:** 2015-11

#### Study First Post Date
**Date:** 2012-11-21
**Type:** ESTIMATED
**Study First Submit Date:** 2012-11-16
**Study First Submit QC Date:** 2012-11-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Philips Electronics Nederland B.V. acting through Philips CTO organization

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Philips Healthcare

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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:** 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.

### Conditions Module

**Conditions:**

- 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

**Keywords:**

- spectroscopy

- nerve

- muscle

- fat

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 35

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Procedure: Surgical resection

**Label:** Surgical resections

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Surgical resections

**Description:** 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.

**Name:** Surgical resection

**Other Names:**

- lymph node dissection

- resection of parotid gland

- rectal surgery

- soft tumor resection

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Statistical analysis of the difference between diffuse reflectance spectra obtained at nerve tissue and its surrounding tissue measurement locations

**Measure:** Differentiation between nerve tissue and its surrounding tissue

**Time Frame:** Day 0

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Eligible patients are patients of the Netherlands Cancer Institute (NKI-AvL), who are scheduled for an elective inguinal, axillary or cervical lymph node dissection, or parotidectomy as well as patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Amsterdam

**Country:** Netherlands

**Facility:** Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis

**State:** Noord-Holland

**Zip:** 1066 CX

#### Overall Officials

**Official 1:**

**Affiliation:** Nederlands Kanker Instituut/Antonie van leeuwenhoek Ziekenhuis

**Name:** Theo Ruers, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

- ID: D000009371

- Term: Neoplasms by Site

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M11220

- Name: Lymphoma

- Relevance: HIGH

- As Found: Malignant Lymphoma

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M15785

- Name: Soft Tissue Neoplasms

- Relevance: HIGH

- As Found: Tumor of Soft Tissue

- ID: M21089

- Name: Facies

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T3543

- Name: Lymphosarcoma

- Relevance: HIGH

- As Found: Malignant Lymphoma

### Condition Browse Module - Meshes

- ID: D000008223

- Term: Lymphoma

- ID: D000012983

- Term: Soft Tissue Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
