Optical Detection of Malignancy During Percutaneous Interventions

Philips

Status: Completed

Conditions: Breast Cancer; Pulmonary Coin Lesion; Colon Cancer Liver Metastasis

Treatments: Procedure: Core biopsy procedure

Study type: Observational

Funder types: Industry

Identifiers

NCT01730365

NL40578.031.12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

104 participants in 1 patient group

Histological biopsy procedures

Description:

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

Treatment:

Procedure: Core biopsy procedure