Optical Detection of Malignancy During Percutaneous Interventions
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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 |
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 |
- Differentiation between normal and malignant tissue [ Time Frame: Day 0 ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 70 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Histological biopsy procedures
Patients with a suspicious lesion in lung or liver 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 or liver or colorectal liver metastasis.
Other Names:
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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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Eligible patients are all patients, who are scheduled for a standard core biopsy of either lung or liver, 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.
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
Contacts and Locations| Contact: Theo Ruers, MD | +31 020 5152565 | t.ruers@nki.nl |
| Contact: Jarich Spliethoff, MSc | +31 020 5127491 | j.spliethoff@nki.nl |
| Netherlands | |
| Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis | Recruiting |
| Amsterdam, Noord-Holland, Netherlands, 1066 CX | |
| Contact: Jarich Spliethoff, MSc +31 020 5127491 j.spliethoff@nki.nl | |
| Sub-Investigator: Warner Prevoo, MD | |
| Sub-Investigator: Jarich Spliethoff, MSc | |
| Principal Investigator: | Theo Ruers, MD | Nederlands Kanker Instituut/Antonie van leeuwenhoek Ziekenhuis |
More Information
No publications provided
| Responsible Party: | Philips Healthcare |
| ClinicalTrials.gov Identifier: | NCT01730365 History of Changes |
| Other Study ID Numbers: | NL40578.031.12 |
| Study First Received: | October 4, 2012 |
| Last Updated: | December 3, 2012 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by Philips Healthcare:
|
spectroscopy tumour biopsy malignancy |
Additional relevant MeSH terms:
|
Colonic Neoplasms Solitary Pulmonary Nodule Neoplasm Metastasis Liver Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Neoplastic Processes Pathologic Processes Liver Diseases |
ClinicalTrials.gov processed this record on June 18, 2013