Rapid Needle Biopsy Assessment at Point of Care to advance personalized cancer therapy

护理点快速针活检评估以推进个性化癌症治疗

• 批准号: 9886701
• 负责人: Eric J Seibel
• 金额: $ 29.75万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9886701
• 关键词: Automation; Biological Markers; Biopsy; Breast; California; Carcinoma; Characteristics; Classification; Clinical; Computers; Core Biopsy; Data Analyses; Dehydration; Development; Devices; Diagnosis; Epidermal Growth Factor; Estrogen Receptors; Evaluation; Feasibility Studies; Feedback; Fluorescence; Formalin; Fresh Tissue; Future; Genomics; Goals; Guidelines; Histopathology; Human; Image; Immunophenotyping; Individual; Intervention; Legal patent; Lesion; Liquid substance; Lung; Malignant Neoplasms; Manuals; Measures; Methods; Microdissection; Microscopy; Microtomy; Molecular; Molecular Probes; Morphology; Multiomic Data; Needle biopsy procedure; Needles; Pancreas; Paraffin Embedding; Pathology; Phenotype; Precision therapeutics; Preparation; Procedures; Process; Progesterone Receptors; Proteomics; Pump; RNA; Sampling; Series; Shapes; Specimen; Speed; Stains; Standardization; Structure; Surface; System; Technology; Testing; Therapeutic; Time; Tissue Preservation; Tissue Procurements; Tissue Sample; Tissue Stains; Tissue Viability; Tissues; Triage; Tube; Universities; Validation; Washington; Work; base; breast cancer diagnosis; cancer biomarkers; cancer cell; cancer subtypes; cancer therapy; computerized; design; epigenomics; fluorescence imaging; image processing; instrumentation; malignant breast neoplasm; metabolomics; minimally invasive; molecular marker; multimodality; novel; personalized cancer therapy; personalized medicine; point of care; preservation; prevent; processing speed; protein expression; prototype; radiologist; response; robot control; sample fixation; tissue trauma; transcriptomics; treatment planning; tumor; ultraviolet; virtual

Project Summary Currently there are no standard guidelines followed for core needle biopsy (CNB) acquisition and preparation. Millions of CNBs are procured annually as the preferred minimally invasive procedure for diagnosing breast cancer and assessing therapeutic strategies based on biomarkers from these small biospecimens. However, the downstream steps in pathology were originally not designed for CNBs – a series of manual procedures that are not standardized. These are: adequacy testing, fixation & dehydration, paraffin embedding, thin-sectioning, staining for image-based morphological analysis, immuno-histochemical (IHC) analysis, and subsequent microdissection to enrich for RNA extraction. Our project is designed to rapidly evaluate the CNB for adequacy, the presence of cancer cells to make a diagnosis, using CoreView millifluidic device from the University of Washington, Seattle. Automated computer-controlled fluidic pumps help to remove the CNB from the needle, transport, clean and stain the tissue surface in a repeatable system designed for CNBs. In partnership with the University of California at Davis, the new method of microscopy with ultraviolet surface excitation will be used which rapidly produces images appear to match the standard H&E images used for adequacy testing. In addition, MUSE will be expanded to include multiplexed molecular of the same CNB. High clinical impact for personalized medicine is provided by this multiplexed fluorescence immunostaining of the biopsy to determine ER/PR and HER2 expression levels that are co-registered with the virtual H&E. The entire process of multiplexed MUSE imaging at the point of care allows the specimen to remain unfixed during this process, which triages one of the CNBs into genomic and other ‘omics analyses in the future that require high yield and quality of biomarkers. The other 1 or 2 CNBs can continue into formalin fixed paraffin embedded conventional histopathology work flow for the future validation of this rapid assessment system. In this feasibility study, the first molecular and morphological CNB instrumentation will be designed and fabricated based on CoreView-MUSE patented technologies. Testing will compare the CNB surface images compared to conventional thin section H&E and IHC as well as the quality and quantity of RNA from these two approaches. Pilot testing of full automation will determine the ultimate speed of processing from needle to multimodal adequacy determination that should range from 5 to 15 minutes at the point of care. Once developed and validated for breast cancer, the CoreView-MUSE system will be expanded to lung, pancreas, and other cancers that rely on CNB accurately sampling cancer from the lesion and providing phenotype classifications for precision therapies.

项目总结