Optical Detection of Malignancy During Percutaneous Interventions
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|ClinicalTrials.gov Identifier: NCT01730365|
Recruitment Status : Completed
First Posted : November 21, 2012
Last Update Posted : April 11, 2016
|Condition or disease||Intervention/treatment|
|Pulmonary Coin Lesion Colon Cancer Liver Metastasis Breast Cancer||Procedure: Core biopsy procedure|
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.
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.
|Study Type :||Observational|
|Actual Enrollment :||104 participants|
|Official Title:||Discrimination of Benign and Malignant Human Tissue During Percutaneous Interventions Using Optical Spectroscopy Techniques|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
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.
- 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
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
|Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis|
|Amsterdam, Noord-Holland, Netherlands, 1066 CX|
|Principal Investigator:||Theo Ruers, MD||Nederlands Kanker Instituut/Antonie van leeuwenhoek Ziekenhuis|