- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04180592
Real Time MRI Fused to Cone Beam CT Guided Biopsies of the Prostate.
Real Time MRI Fused to Cone Beam CT Guided Biopsies of the Prostate: The Safety and Feasibility of a Novel Method of Prostate Biopsy.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
This will be a prospective randomized controlled trial using a cross over design. Patients will serve as their own controls and undergo both TRUSP biopsy (standard of care) and mpMRI fused to cone beam CT guided biopsy of the prostate. The procedures and recovery will follow the identical standardized care pathway that is currently used for TRUSP biopsies. A total of 20 patients will be recruited
Patients will be randomized to receive either TRUSP biopsy or cone beam CT guided biopsy first, followed by the alternative procedure. Following the initial biopsy procedure the patients will fill out a short pain score. They will then recover in the radiology suite for a period of one hour. Following a one hour recovery period the patient will subsequently undergo the alternative biopsy procedure. They will then fill out a second pain score with two additional questions asking the patient to compare the two biopsy approaches with respect to comfort and preference using a 7 point Likert scale. Specimens will be sent to pathology separately to detect differences in diagnostic yield between the two biopsy approaches. In order to minimize inter-operator variability in outcomes, Dr. Menard will perform all biopsies regardless of approach.
An interim analysis after 10 patients will be performed. The study will be terminated early if:
- No TRUSP biopsy detects any form of prostate cancer
- No cone beam CT guided biopsy detects any form of prostate cancer.
- Average pain scores between biopsy approaches differ by more than 4 points on the Universal Pain Assessment scale.
3 or more patients suffer any of:
- Immediate procedure related complications
- 30 day return to the emergency room
- 30 day hospital admission
Measures
Feasibility:
Patients will be considered to have clinically significant prostate cancer based on their PI-RADS score 4 or 5. The ability of TRUSP biopsy and cone beam CT guided biopsy to detect any form of prostate cancer as well as clinically significant prostate cancer (defined as prostate cancer with a Gleason score ≥7) will serve as the primary outcome measures.
Safety:
Immediate procedure related complications, 30 day return to the ER and 30 day hospital admission rates will be recorded. Immediate procedure related complications will be documented at the time of the procedure. The 30 day return to the ER and hospital admission rates will be documented at the participant's followup appointment. Complication rates will reflect the total combined complication rate. This can be compared against the known Ontario province rates to ensure that the addition of cone beam CT guided biopsy does not provide for additive morbidity.
Tolerability:
Patients will fill out the Universal Pain Assessment Tool after each procedure. After both procedures are completed, patients will fill out two questions utilizing a 7 point Likert scale on preference and comfort between the two biopsy approaches.
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Jason P Izard, MD
- Номер телефона: 613-548-2493
- Электронная почта: jason.izard@kingstonhsc.ca
Места учебы
-
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Ontario
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Kingston, Ontario, Канада, K7L 2V7
- Рекрутинг
- Kingston Health Sciences Centre
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Контакт:
- Jason Izard, MD
- Номер телефона: 6135482493 613-548-2493
- Электронная почта: jason.izard@kingstonhsc.ca
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
Participants will be eligible for enrollment if they have both of:
- Lesion in the prostate on mpMRI that is highly likely to be clinically significant prostate cancer based on the PI-RADS version 2 score (PI-RADS score of 4 or 5).
- A previous negative TRUSP biopsy or previous TRUSP biopsy showing atypical small acinar proliferation, high grade prostatic intraepithelial neoplasia or low volume Gleason 6 disease (low risk disease) all of which are incongruent with the high PI-RADS score of the mpMRI lesion.
Exclusion Criteria:
- Uncorrected coagulopathy.
- Active, untreated urinary tract infection.
- Inability to access the rectum in order to perform TRUSP biopsy.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Диагностика
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: CT Fusion Biopsy + Transrectal U/S Guided Prostate Biopsy
All patients will receive both a CT fusion biopsy and a standard TRUSP biopsy.
They will be randomized to which is received first, followed by receipt of the alternative procedure.
|
All patients will receive both a CT fusion biopsy and a standard TRUSP biopsy.
They will be randomized to which is received first, followed by receipt of the alternative procedure.
|
Другой: Transrectal U/S Guided Prostate Biopsy + CT Fusion Biopsy
All patients will receive both a CT fusion biopsy and a standard TRUSP biopsy.
They will be randomized to which is received first, followed by receipt of the alternative procedure.
|
All patients will receive both a CT fusion biopsy and a standard TRUSP biopsy.
They will be randomized to which is received first, followed by receipt of the alternative procedure.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Accuracy of CT fusion biopsy [number of biopsies that show clinically significant prostate cancer]
Временное ограничение: Day 0
|
Patients will be considered to have clinically significant prostate cancer based on their PI-RADS score 4 or 5.
The ability of TRUSP biopsy and cone beam CT guided biopsy to detect any form of prostate cancer as well as clinically significant prostate cancer (defined as prostate cancer with a Gleason score ≥7) will serve as the primary outcome measures.
|
Day 0
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Временное ограничение: 0 Day and at 30 day
|
Immediate procedure related complications will be documented at the time of procedures.
The 30 day return to the ER and hospital admission rates will be documented at the participant's following appointment.
|
0 Day and at 30 day
|
Tolerability of CT fusion biopsy
Временное ограничение: Day 0
|
Patients will fill out the 0-10 point Universal Pain Assessment Tool after each procedure where 0 is no pain and 10 is the worst pain possible.
After both procedures are completed, patients will also fill out two questions utilizing a 1-7 point Likert scale on preference and comfort between the two biopsy approaches where 1 represents rectum biopsy and 7 represents buttock muscle biopsy.
|
Day 0
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 6018147
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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