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Optical Detection of Malignancy During Percutaneous Interventions

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Philips Healthcare
Sponsor:
Information provided by (Responsible Party):
Philips Healthcare
ClinicalTrials.gov Identifier:
NCT01730365
First received: October 4, 2012
Last updated: May 12, 2014
Last verified: August 2013
  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 ] [ 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: June 2015
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730365

Contacts
Contact: Theo Ruers, MD +31 020 5152565 t.ruers@nki.nl
Contact: Jarich Spliethoff, MSc +31 020 5127491 j.spliethoff@nki.nl

Locations
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         
Sponsors and Collaborators
Philips Healthcare
Investigators
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: May 12, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Philips Healthcare:
spectroscopy
tumour
biopsy
malignancy

Additional relevant MeSH terms:
Breast Neoplasms
Solitary Pulmonary Nodule
Breast Diseases
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Skin Diseases
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014