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Optical Detection of Malignancy During Percutaneous Interventions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01730365
First Posted: November 21, 2012
Last Update Posted: April 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Philips Healthcare
  Purpose
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.

Condition Intervention
Pulmonary Coin Lesion Colon Cancer Liver Metastasis Breast Cancer Procedure: Core biopsy procedure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Discrimination of Benign and Malignant Human Tissue During Percutaneous Interventions Using Optical Spectroscopy Techniques

Resource links provided by NLM:


Further study details as provided by Philips Healthcare:

Primary Outcome Measures:
  • 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


Biospecimen Retention:   Samples Without DNA
Biopsies are taken from the enrolled patients and these biopsies are send to the pathology department for histopathological analysis.

Enrollment: 104
Study Start Date: October 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Histological biopsy procedures
Patients with a suspicious lesion in lung or liver or breast who are planned for a standard core biopsy procedure. And patients planned for percutaneous RFA (Radiofrequency Ablation) of colorectal liver metastasis
Procedure: Core biopsy procedure
Core biopsy of suspicious lesion in lung, liver, breast, or colorectal liver metastasis.
Other Names:
  • Histological biopsy procedure
  • Standard biopsy procedure

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible patients are all patients, who are scheduled for a standard core biopsy of lung, liver or breast; or percutaneous RFA of liver in the Netherlands Cancer Institute (NKI-AvL), Amsterdam, The Netherlands. In the enrollment process the "patient informatie" will be used and the informed consent must be signed prior to the intervention.
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730365


Locations
Netherlands
Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis
Amsterdam, Noord-Holland, Netherlands, 1066 CX
Sponsors and Collaborators
Philips Healthcare
Investigators
Principal Investigator: Theo Ruers, MD Nederlands Kanker Instituut/Antonie van leeuwenhoek Ziekenhuis
  More Information

Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT01730365     History of Changes
Other Study ID Numbers: NL40578.031.12
First Submitted: October 4, 2012
First Posted: November 21, 2012
Last Update Posted: April 11, 2016
Last Verified: April 2016

Keywords provided by Philips Healthcare:
spectroscopy
tumour
biopsy
malignancy

Additional relevant MeSH terms:
Solitary Pulmonary Nodule
Lung Diseases
Respiratory Tract Diseases