Optical Detection of Malignancy During Percutaneous Interventions

Sponsor

Philips Healthcare (Industry)

Overall Status

Completed

CT.gov ID

NCT01730365

Collaborator

(none)

104

Enrollment

Location

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Coin Lesion Colon Cancer Liver Metastasis Breast Cancer	Procedure: Core 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.

Study Design

Study Type:

Observational

Actual Enrollment :

104 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis	Amsterdam	Noord-Holland	Netherlands	1066 CX

Sponsors and Collaborators

Philips Healthcare

Investigators

Principal Investigator: Theo Ruers, MD, Nederlands Kanker Instituut/Antonie van leeuwenhoek Ziekenhuis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Philips Healthcare

ClinicalTrials.gov Identifier:

NCT01730365

Other Study ID Numbers:

NL40578.031.12

First Posted:

Nov 21, 2012

Last Update Posted:

Apr 11, 2016

Last Verified:

Apr 1, 2016

Keywords provided by Philips Healthcare

Additional relevant MeSH terms:

Solitary Pulmonary Nodule

Study Results

No Results Posted as of Apr 11, 2016