Clinical trial NCT01730365: Optical Detection of Malignancy During Percutaneous Interventions
Official title: Discrimination of Benign and Malignant Human Tissue During Percutaneous Interventions Using Optical Spectroscopy Techniques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Coin Lesion
Colon Cancer Liver Metastasis
Breast Cancer
Keywords: spectroscopy
tumour
biopsy
malignancy
Lead sponsor: Philips Healthcare
Sponsor class: INDUSTRY
First posted: 2012-11-21
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients are all patients, who are scheduled for a standard core biopsy of lung, liver or breast; or percutaneous RFA of liver in the Netherlands Cancer Institute (NKI-AvL), Amsterdam, The Netherlands. In the enrollment process the "patient informatie" will be used and the informed consent must be signed prior to the intervention.

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.

Eligibility 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)

Primary outcomes:
measure: Differentiation between normal and malignant tissue
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis
state: Noord-Holland
Study officials:
affiliation: Nederlands Kanker Instituut/Antonie van leeuwenhoek Ziekenhuis
name: Theo Ruers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Boer LL, Bydlon TM, van Duijnhoven F, Vranken Peeters MTFD, Loo CE, Winter-Warnars GAO, Sanders J, Sterenborg HJCM, Hendriks BHW, Ruers TJM. Towards the use of diffuse reflectance spectroscopy for real-time in vivo detection of breast cancer during surgery. J Transl Med. 2018 Dec 19;16(1):367. doi: 10.1186/s12967-018-1747-5.