Optical Detection of Malignancy During Percutaneous Interventions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pulmonary Coin Lesion Colon Cancer Liver Metastasis Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

Core biopsy procedure

Intervention Type PROCEDURE

Core biopsy of suspicious lesion in lung, liver, breast, or colorectal liver metastasis.

Interventions

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Core biopsy procedure

Core biopsy of suspicious lesion in lung, liver, breast, or colorectal liver metastasis.

Intervention Type PROCEDURE

Other Intervention Names

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Histological biopsy procedure Standard biopsy procedure

Eligibility Criteria

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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

Exclusion Criteria

* Patients who have higher risk of bleeding
* Patients with suspected sensitivity to light; e.g. patients who have had photodynamic therapy

* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No