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OpenTrials
Completed

NCT Number: NCT01730365

Optical Detection of Malignancy During Percutaneous Interventions

Investigation of application possibilities of optical spectroscopy within the field of oncology. 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. biopsy needle) would enlarge the accuracy and reliability of these devices. The purpose is to improve and speed up the diagnostics and therapy of the malignancies.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis

Amsterdam, North Holland, 1066 CX, Netherlands

About this study

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, liver, and breast.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Breast patients with a BIRADS score 4 or 5

General Exclusion criteria:

  • Patients who have higher risk of bleeding
  • Patients with suspected sensitivity to light; e.g. patients who have had photodynamic therapy

Breast Specific Exclusion criteria:

  • Patients who have a history of breast cancer and/or who have received prior chemotherapy, endocrine therapy, or radiation therapy
  • Patients who have breast implants
  • Patients needing a stereotactic breast biopsy (i.e. non palpable-, ultrasound opaque lesions)

Treatment and study plan

Core biopsy procedure

Procedure

Core biopsy of suspicious lesion in lung, liver, breast, or colorectal liver metastasis.

Other names: Histological biopsy procedure, Standard biopsy procedure

Primary outcomes

  1. Differentiation between normal and malignant tissue

    Time frame: Day 0

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

Sponsors and collaborators

Lead sponsor

Philips Healthcare

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 21, 2012
Registry last updated
Apr 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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