Optical Detection of Malignancy During Percutaneous Interventions

Completed

• Conditions: Pulmonary Coin Lesion; Breast Cancer; Colon Cancer Liver Metastasis
• Interventions: Procedure: Core biopsy procedure

• Registration Number: NCT01730365
• Lead Sponsor: Philips Healthcare

Brief 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.

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-04
• Study First Submitted QC: 2012-11-15
• Study First Posted: 2012-11-21
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-08
• Last Update Posted: 2016-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Histological biopsy procedures	Core biopsy procedure	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

Primary Outcome Measures

Name	Time	Method
Differentiation between normal and malignant tissue	Day 0	Statistical analysis of the difference between diffuse reflectance spectra obtained at normal and malignant measurement locations

Trial Locations

Locations (1)

Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis; 🇳🇱 Amsterdam, Noord-Holland, Netherlands