Optical Detection of Malignancy During Percutaneous Interventions

NCT01730365 | Completed DMC

• 1 other identifier: NL40578.031.12
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Coin Lesion; Colon Cancer Liver Metastasis; Breast Cancer

Keywords

spectroscopy; tumour; biopsy; malignancy

Outcome Measures

Primary Outcomes (1)

• Differentiation between normal and malignant tissue

  Statistical analysis of the difference between diffuse reflectance spectra obtained at normal and malignant measurement locations

  Day 0

Study Arms (1)

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

Interventions

Core biopsy procedure PROCEDURE

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

Also known as: Histological biopsy procedure, Standard biopsy procedure

Histological biopsy procedures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Philips Healthcare: lead

Study Sites (1)

Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis

Amsterdam, North Holland, 1066 CX, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 30567584 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsies are taken from the enrolled patients and these biopsies are send to the pathology department for histopathological analysis.

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Theo Ruers, MD

  Nederlands Kanker Instituut/Antonie van leeuwenhoek Ziekenhuis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2012
• First Posted: November 21, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 11, 2016

Record last verified: 2016-04

Locations

NL (1)