Clinical trial NCT01731379: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Philips Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Philips Electronics Nederland B.V. acting through Philips CTO organization
First posted: 2012-11-21
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

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.

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

Primary outcomes:
measure: Differentiation between nerve tissue and its surrounding tissue
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis
state: Noord-Holland
Study officials:
affiliation: Nederlands Kanker Instituut/Antonie van leeuwenhoek Ziekenhuis
name: Theo Ruers, MD
role: PRINCIPAL_INVESTIGATOR
References: