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Идёт набор NCT06904313

Ultralow Dose PET Imaging for PSMA Expression

Фаза II С лечением Healthy Volunteer Prostate CA

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: Piflufolastat F18.
Кому может быть актуально
Состояния в реестре: Healthy Volunteer, Prostate CA. Базовые параметры: 18 лет — 120 лет · Все.
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

Evaluation of Ultralow Dose PET Imaging for Detecting PSMA Expression

Обзор

The goal of this clinical trial is to evaluate an investigational ultralow dose PET imaging technique for prostate cancer detection and monitoring. The main question it aims to answer is: Can the investigators optimize the timing, scan duration, and image reconstruction to reduce the radiation dose 10-100 fold of the current clinical standard? Participants will be injected with a radioactive tracer called 18F-DCFPyL and be imaged on a new type of high sensitivity PET scanner for up to 3 hours

Подробное описание

This research study aims to evaluate an investigational ultralow dose PET imaging technique for prostate cancer detection and monitoring. "Investigational" means that the procedure or drug being studied is not yet approved by the FDA for the specific use being tested in this research. The PET imaging technique used in this study is considered investigational because it is being tested at an ultralow radiation dose that has not yet been approved for clinical use. The radiotracer, 18F-DCFPyL, is FDA-approved for detecting prostate cancer at standard doses.

18F-DCFPyL attaches to a protein called PSMA, which is often found at higher levels on certain cancer cells, such as prostate cancer cells. In this study, investigators will use a very small amount of this tracer (less than 1/20th of the standard dose) along with advanced PET imaging technology to see if it is possible to create clear images while using much less radiation. This study aims to develop a safer imaging technique that could potentially be used more frequently for screening and monitoring prostate cancer.

Investigators will enroll individuals with and without prostate cancer to evaluate how ultralow dose PET imaging detects PSMA in different type of tissue.

Approximately 200 people will be enrolled in this study at the Nuclear Imaging Institute.

Вмешательства

  • Препарат Piflufolastat F18
    Participants will be injected with Piflufolastat F18 and imaged for up to 3 hours on a PET scanner

Первичные конечные точки

  • Signal-to-Noise Ratio (SNR) [Срок оценки: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.]
  • Contrast-to-Noise Ratio (CNR) [Срок оценки: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.]
  • Coefficient of Variation (COV) [Срок оценки: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.]
  • Spatial Resolution (Full Width at Half Maximum - FWHM) [Срок оценки: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.]
  • Target-to-Background Ratio (TBR) [Срок оценки: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.]
  • Qualitative Image Quality Score (Likert Scale) [Срок оценки: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.]
  • Inter-reader Agreement (Weighted Kappa Statistics) [Срок оценки: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.]

Критерии участия

Критерии включения

  • Age ≥18 years.
  • Ability to provide informed consent and comply with study procedures.
  • For female participants:
  • Must not be pregnant or breastfeeding.
  • Negative pregnancy test required for women of childbearing potential.

Критерии исключения

  • Participants who have exceeded NRC regulation for annual radiation exposure from prior research-related scans, including this study (50 mSv total).
  • More than four prior enrollments in this study.
  • Participants with severe claustrophobia, chronic pain, or musculoskeletal conditions that prevent completion of the PET scan
  • Medication \& Prior Treatment Exclusions
  • Concurrent PSMA-targeted therapy (e.g., lutetium-177).
  • Pregnant or breastfeeding individuals (negative pregnancy test required)
  • Inability to provide informed consent
  • Any condition that, in the investigator's judgment, may compromise participant safety or study integrity.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

США · 1 центр
  • Nuclear Imaging Institute — Englewood

Идентификаторы

NCT: NCT06904313 · NII-0001-PSMA

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗