Multicenter clinical experience with large core soft tissue biopsy without vacuum assistance

Area of Science:

• Oncology
• Pathology
• Medical Devices

Background:

• Accurate pretreatment diagnosis of solid tumors is crucial for effective treatment planning.
• Current methods for obtaining large core biopsies must balance diagnostic accuracy with minimal tissue injury and patient comfort.
• There is a need for advanced biopsy devices that meet clinical, technical, and financial requirements.

Purpose of the Study:

• To evaluate a novel large core soft tissue biopsy device for solid tumor diagnosis.
• To assess the device's performance in terms of tissue sample quality, diagnostic yield, and patient tolerance.
• To determine if the device meets requirements for minimal tissue injury, affordability, and patient compliance.

Main Methods:

• A new large core soft tissue biopsy device was developed and underwent preclinical testing.
• Thirty patients provided informed consent, and 26 underwent the new biopsy procedure.
• Biopsy samples were analyzed using morphology, immunohistochemistry, and molecular biology.

Main Results:

• The new biopsy system successfully obtained diagnostic samples in 25 out of 26 procedures.
• Complete diagnoses were achieved for morphology, immunohistochemistry, and molecular biology in 25 patients.
• The system demonstrated minimal injury to breast parenchyma and no artefacts in tissue specimens, meeting technical and financial requirements.

Conclusions:

• The novel large core soft tissue biopsy system is effective for accurate solid tumor diagnosis.
• The device minimizes tissue injury and provides high-quality samples suitable for comprehensive analysis.
• Further automation of the technique is being developed to enhance its clinical utility.