Comparing Standard of Care Biopsy System to a Novel Biopsy Needle System by Computational Pathologic Analysis

Официальное название

Comparing a Standard of Care Prostate Biopsy System with a Novel System Using Standard As Well As Computational Pathology Analyses to Measure Clinical and Morphometric Parameters.

Обзор

Prostate biopsy is the definitive examination to establish the diagnosis of prostate cancer, but up to 40% of these biopsies overestimate or underestimate the severity of the disease. A novel biopsy needle system captures substantially more tissue than standard of care needles, but it is important to assess the retrieval of tissue for pathologic analyses. This study will compare quality and quantity of tissue retrieved by both systems. Further, tissue will be analyzed using computational pathology algorithms for atypical small acinar proliferation and Gleason scores in terms of tissue area, tissue length, and tissue tortuosity.

Подробное описание

Prostate tissue captured in needle biopsy procedures are used to diagnose prostate cancer, but current biopsy systems (standard of care control device) have been shown to underperform when compared to a new novel needle biopsy system (test device). The objectives of the study are to (1) compare tissue quality between test and control devices; (2) compare diagnostic ambiguity between the two devices; and (3) compare tissue area, length, and tortuosity from the samples with a computational pathology algorithm. Tissue analyses will be completed by pathologists blinded to the biopsy system used.

Вмешательства

• Устройство Novel needle biopsy catheter (test)
  Tissue is collected from the prostate by introducing a needle into the prostate and cutting out a sample

Первичные конечные точки

• Atypical Small Acinar Proliferation [Срок оценки: From enrollment to end of treatment at 1 day]
• Gleason Score [Срок оценки: From enrollment to end of treatment at 1 day]
• Tissue area and length [Срок оценки: From treatment to end of pathology review at 2 days]
• Tissue toruosity [Срок оценки: From treatment to end of pathology review at 2 days]

Вторичные конечные точки (1)

• Standard Pathology versus Computational Pathology Results [Срок оценки: From treatment to end of pathology review at 2 days]

Критерии участия

Критерии включения

• Adult males with PSA density greater than or equal to 0.15
• Lesions are visible under MRI
• PIRADS score is greater than or equal to 3
• Able to and willing to provide consent

Критерии исключения

• Subject has had previous local prostate therapy, focal therapy, brachytherapy, ADT, surgery, or chemotherapy for prostate cancer
• History of dementia, cognitive impairment, or deep vein thrombosis (DVT)
• Is a prisoner currently or has a history of incarceration
• Unable to understand English
• Has metastatic prostate cancer or a tumor stage of T2c, T3, or T4
• Has concurrent malignancies
• Is positive for HIV, HBV, and/or HCV infection
• Has low-performance status

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Простое слепое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06830265 · 25-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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