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Optical Detection of Malignancy During Percutaneous Interventions

Information source: Philips Healthcare
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Coin Lesion; Colon Cancer Liver Metastasis; Breast Cancer

Intervention: Core biopsy procedure (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Philips Healthcare

Official(s) and/or principal investigator(s):
Theo Ruers, MD, Principal Investigator, Affiliation: Nederlands Kanker Instituut/Antonie van leeuwenhoek Ziekenhuis

Overall contact:
Theo Ruers, MD, Phone: +31 020 5152565, Email: t.ruers@nki.nl

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.

Clinical Details

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

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

Primary outcome: Differentiation between normal and malignant tissue

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

Theo Ruers, MD, Phone: +31 020 5152565, Email: t.ruers@nki.nl

Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis, Amsterdam, Noord-Holland 1066 CX, Netherlands; Recruiting
Jarich Spliethoff, MSc, Phone: +31 020 5127491, Email: j.spliethoff@nki.nl
Warner Prevoo, MD, Sub-Investigator
Jarich Spliethoff, MSc, Sub-Investigator
Additional Information

Starting date: October 2012
Last updated: March 19, 2015

Page last updated: August 23, 2015

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