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Discrimination of Benign and Malignant Human Tissue During Percutaneous Interventions Using Optical Spectroscopy Techniques


N/A
18 Years
N/A
Open (Enrolling)
Both
Pulmonary Coin Lesion, Colon Cancer Liver Metastasis

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Trial Information

Discrimination of Benign and Malignant Human Tissue During Percutaneous Interventions Using Optical Spectroscopy Techniques


Primary Objective:

In this observational study the investigators aim to evaluate whether optical spectroscopy
can correctly diagnose malignant tissue in the existing clinical workflow of percutaneous
interventions in lung and liver.

Secondary Objective:

During the measurement procedure, possible improvements 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. Special attention will
be paid to observe how the procedure fits in the standard workflow of the radiologist.


Inclusion Criteria:



- Patients with a suspicious lesion in lung or liver who are scheduled for a standard
core biopsy procedure

- Patient planned for percutaneous RFA of colorectal liver metastasis

- Written informed consent

- Patients ≥ 18 years old

Exclusion Criteria:

- Patients who have higher risk of bleeding

- 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 normal and malignant tissue

Outcome Description:

Statistical analysis of the difference between diffuse reflectance spectra obtained at normal and malignant 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:

NL40578.031.12

NCT ID:

NCT01730365

Start Date:

October 2012

Completion Date:

September 2013

Related Keywords:

  • Pulmonary Coin Lesion
  • Colon Cancer Liver Metastasis
  • spectroscopy
  • tumour
  • biopsy
  • malignancy
  • Colonic Neoplasms
  • Solitary Pulmonary Nodule
  • Neoplasm Metastasis
  • Liver Neoplasms

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