Набор скоро начнётся NCT07075705

Transperineal Micro-ultrasound for the Detection of Prostate Cancer During Biopsy

Без фазы С лечением Prostate Carcinoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Biopsy of Prostate, Magnetic Resonance Imaging, Micro-ultrasound Imaging, Micro-ultrasound Imaging.
Кому может быть актуально: Состояния в реестре: Prostate Carcinoma. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Investigating the Feasibility of Using Transperineal Micro-Ultrasound to Detect Clinically Significant Prostate Cancer

Обзор

This clinical trial studies whether transperineal micro-ultrasound can be used to detect prostate cancer during biopsy. Transrectal ultrasound is often used during prostate biopsy. Transrectal ultrasound imaging is a procedure in which a probe that sends out high-energy sound waves is inserted into the rectum. The sound waves are bounced off internal tissues or organs and make echoes. The echoes form a picture of body tissue called a sonogram. Transrectal ultrasound is used to look for abnormalities in the rectum and nearby structures, including the prostate. The images are used to guide the prostate biopsy. Transperineal micro-ultrasound is completed by placing a probe over the skin between the scrotum and anus (perineum). It is a high-resolution ultrasound at 29 megahertz (MHz) (compared to traditional ultrasound at 6-9 MHz). This higher frequency allows for an improved spatial resolution. This improved spatial resolution is approximately the diameter of a prostatic duct, and therefore, may be able to visualize slight changes in the structure of prostatic ducts that are not possible with standard transrectal ultrasound. Transperineal micro-ultrasound may be more effective in detecting prostate cancer during biopsy.

Подробное описание

PRIMARY OBJECTIVES:

I. To investigate the feasibility and validity of using transperineal micro-ultrasound to image the prostate and detect clinically significant prostate cancer.

II. To test the quality of visualization of the prostate gland using micro-ultrasound via the transperineal approach.

SECONDARY OBJECTIVE:

I. To compare micro-ultrasound images done via the transperineal method to micro-ultrasound images done via the transrectal method to see if transperineal ultrasound has similar ability to detect suspicious prostate lesions as transrectal micro-ultrasound.

OUTLINE:

Patients undergo transperineal micro-ultrasound imaging over 3 minutes followed by transrectal micro-ultrasound imaging during standard of care prostate biopsy. Patients also undergo magnetic resonance imaging (MRI) during screening.

Вмешательства

Процедура Biopsy of Prostate
Undergo standard of care prostate biopsy
Процедура Magnetic Resonance Imaging
Undergo MRI
Процедура Micro-ultrasound Imaging
Undergo transperineal micro-ultrasound imaging
Процедура Micro-ultrasound Imaging
Undergo transrectal micro-ultrasound imaging

Первичные конечные точки

Proportion of patients with Prostate Risk Identification Using Micro-Ultrasound (PRIMUS) score (Feasibility) [Срок оценки: Up to 2 months]
Visualization of the prostate from base to apex with adequate image quality for PRIMUS scoring [Срок оценки: Up to 2 months]
Visualization of the prostate from right and left lateral margins with adequate image quality for PRIMUS scoring [Срок оценки: Up to 2 months]

Вторичные конечные точки (3)

Successful generation of PRIMUS score in transperineal and transrectal ultrasound images [Срок оценки: Up to 7 months]
Ability to visualize the whole prostate using transperineal micro-ultrasound [Срок оценки: Up to 7 months]
Quality of images of transperineal ultrasound and transrectal ultrasound of the prostate [Срок оценки: Up to 7 months]

Критерии участия

Критерии включения

Men aged ≥ 18 years
Men scheduled for transrectal ultrasound guided prostate biopsy who have had a prebiopsy MRI. Therefore patients unable to have a prebiopsy MRI who have contraindications to MRI or unwilling to undergo MRI would be excluded
The participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board-approved written informed consent form before receiving any study-related procedure