Optical Detection of Malignancy During Percutaneous Interventions

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01730365
• Other study ID #: NL40578.031.12
• Status: Completed
• Phase: N/A
• First received: October 4, 2012
• Last updated: April 8, 2016
• Start date: October 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Philips Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer Liver Metastasis
• Pulmonary Coin Lesion

Intervention

Procedure:
• Core biopsy procedure
Core biopsy of suspicious lesion in lung, liver, breast, or colorectal liver metastasis.

Locations

Country	Name	City	State
Netherlands	Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Philips Healthcare

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differentiation between normal and malignant tissue	Statistical analysis of the difference between diffuse reflectance spectra obtained at normal and malignant measurement locations	Day 0	No