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


N/A
18 Years
N/A
Open (Enrolling)
Both
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

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Outcome Measure:

Differentiation between nerve tissue and its surrounding tissue

Outcome Description:

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

Outcome Time Frame:

Day 0

Safety Issue:

No

Principal Investigator

Theo Ruers, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Nederlands Kanker Instituut/Antonie van leeuwenhoek Ziekenhuis

Authority:

Netherlands: Medical Ethics Review Committee (METC)

Study ID:

NL 40893.031.12

NCT ID:

NCT01731379

Start Date:

December 2012

Completion Date:

December 2013

Related Keywords:

  • 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
  • spectroscopy
  • nerve
  • muscle
  • fat
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Rectal Neoplasms
  • Colorectal Neoplasms
  • Lymphoma
  • Soft Tissue Neoplasms

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