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Идёт набор NCT06579417

ART-Pro: Clinical Trial Evaluating Biparametric MRI and Advanced, Quantitative Diffusion MRI for Detection of Prostate Cancer

— Наблюдательное Prostate Cancer

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: RSI MRI.
Кому может быть актуально
Состояния в реестре: Prostate Cancer. 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, Великобритания
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

Advanced Restriction Imaging and Reconstruction Technology for Prostate MRI (ART-Pro)

Обзор

This is a multicenter, multinational trial to evaluate advanced MRI techniques for improved detection of clinically significant prostate cancer (csPCa). The study will enroll 500 participants at 5 clinical centers (100 participants per center). The current standard MRI technique for prostate cancer screening is multiparametric MRI (mpMRI), but two drawbacks include need for intravenous (IV) contrast and dependence on radiologist expertise. The investigators expect that the combination of two other techniques, biparametric MRI (bpMRI) and Restriction Spectrum Imaging restriction score (RSIrs), will help non-expert radiologists achieve similar performance to expert radiologists using bpMRI or mpMRI for detection of csPCa, while avoiding the drawbacks that are present when using mpMRI.

Подробное описание

ART-Pro will be conducted in two phases (ART-Pro-1 and ART-Pro-2) and will evaluate bpMRI, mpMRI, and RSIrs (an advanced quantitative diffusion technique), for detection of csPCa. ART-Pro-1 will evaluate these techniques prospectively, by having each patients' MRI exam read by 2 expert radiologists, both using different subsets of the images to evaluate the different techniques. ART-Pro-1 will additionally evaluate RSIrs as a stand-alone quantitative biomarker. ART-Pro-2 will evaluate these same techniques retrospectively using radiologists of varying experience levels (novice, basic, and expert), and findings will be evaluated against the expertly created dataset from ART-Pro-1. Patients will be followed after initial enrollment for the purpose of extracting relevant medical outcomes, such as biopsy results or surgery pathology.

Вмешательства

  • Диагностический тест RSI MRI
    In ART-Pro-1, patients receive standard of care mpMRI, with addition of the RSI sequence, and subsets of the patients' images are read separately by two expert radiologists at the center, one of whom is the standard of care radiologist (Reader 1). Three research reports are generated using: bpMRI only (Reader 1), mpMRI (Reader 1), and bpMRI + RSIrs (Reader 2). The clinical report is submitted by Reader 1. Patients' future prostate cancer management will be recorded and used to evaluate the perfo

Первичные конечные точки

  • Proportion of patients diagnosed with a grade group ≥2 prostate cancer on biopsy [Срок оценки: 6 months]
Вторичные конечные точки (1)
  • Proportion of patients undergoing a biopsy that reveals no cancer or only grade group 1 prostate cancer [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • 18 years of age or older
  • Referred for mpMRI of the prostate for suspicion of prostate cancer
  • MRI is conducted using the standardized ART-Pro acquisition protocol

Критерии исключения

  • Currently incarcerated
  • Previous diagnosis of prostate cancer
  • Active non-prostate tumor(s) in structures of the body near the prostate
  • Previous prostate surgery
  • History of hip implant
  • Metal implants or implanted devices in the body or other criteria that are deemed to require deviation from the usual acquisition protocol or scanning procedures

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 4 центра
  • University of California San Diego — San Diego
  • University of California, San Francisco — San Francisco
  • Massachusetts General Hospital — Boston
  • Weill Cornell Medical College — New York
Великобритания · 1 центр
  • Cambridge University Hospitals NHS Foundation Trust — Cambridge

Публикации

  • Baxter MT, Conlin CC, Bagrodia A, Barrett T, Bartsch H, Brau A, Cooperberg M, Dale AM, Guidon A, Hahn ME, Harisinghani MG, Javier-DesLoges JF, Kamran SC, Kane CJ, Kuperman JM, Margolis DJA, Murphy PM, Nakrour N, Ohliger MA, Rakow-Penner R, Shabaik A, Simko JP, Tempany CM, Wehrli N, Woolen SA, Zou J, Seibert TM. Advanced Restriction Imaging and Reconstruction Technology for Prostate Magnetic Resona PMID 39811103

Идентификаторы

NCT: NCT06579417 · 804875

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗