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Набор скоро начнётся NCT07639801

68Ga-FAPI-PSMA PET Imaging for the Diagnosis of Solid Tumors

Без фазы С лечением Prostate Cancer Hepatocellular Carcinoma Ovarian Cancer Solid Tumors

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: 68Ga-FAPI-PSMA, 68Ga-PSMA-617, 68Ga-FAPI-04.
Кому может быть актуально
Состояния в реестре: Prostate Cancer, Hepatocellular Carcinoma, Ovarian Cancer, Solid Tumors. Базовые параметры: 18 лет — 75 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
Список центров уточняется — проверьте первичный протокол.
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 Dual-Targeted 68Ga-FAPI-PSMA PET/CT for the Diagnosis and Staging of Solid Tumors

Обзор

This study aims to evaluate a novel dual-targeted PET imaging tracer, 68Ga-FAPI-PSMA, for the detection and evaluation of solid tumors. Fibroblast activation protein (FAP) and prostate-specific membrane antigen (PSMA) are two important molecular targets that are highly expressed in tumor cells or the tumor microenvironment. Combining these two targets into a single imaging probe may improve the sensitivity and accuracy of tumor detection. In this single-center, open-label, self-controlled study, approximately 20 patients with suspected or confirmed solid tumors will undergo PET/CT imaging using 68Ga-FAPI-PSMA. The imaging results will be compared with standard PET tracers such as 68Ga-PSMA-617 or 68Ga-FAPI-04. The study will assess tracer uptake in tumor lesions and compare diagnostic performance between imaging methods. The results may help determine whether 68Ga-FAPI-PSMA PET/CT can improve tumor detection, staging, and clinical evaluation in patients with solid tumors.

Вмешательства

  • Лучевая терапия 68Ga-FAPI-PSMA
    Participants will receive an intravenous injection of the investigational PET tracer 68Ga-FAPI-PSMA (0.1-0.15 mCi/kg). Whole-body PET/CT imaging will be performed approximately 1 hour after injection. Delayed imaging at 2-4 hours may be performed when necessary. Imaging results will be used to evaluate tracer uptake in tumor lesions and to assess the diagnostic performance of the dual-targeted tracer.
  • Лучевая терапия 68Ga-PSMA-617
    Participants will receive an intravenous injection of the PET tracer 68Ga-PSMA-617 (0.1-0.15 mCi/kg) followed by PET/CT imaging approximately 1 hour after administration. This imaging serves as a comparator to evaluate the diagnostic performance of the investigational tracer 68Ga-FAPI-PSMA.
  • Лучевая терапия 68Ga-FAPI-04
    Participants may undergo PET/CT imaging using the PET tracer 68Ga-FAPI-04 (0.1-0.15 mCi/kg) with imaging performed approximately 1 hour after injection. This imaging will serve as a comparator for assessing the diagnostic performance of 68Ga-FAPI-PSMA PET/CT.

Первичные конечные точки

  • Standardized Uptake Value (SUV) of Tumor Lesions [Срок оценки: 1-4 hours after injection]
Вторичные конечные точки (3)
  • Tumor-to-Background Ratio (TBR) of Target Tumor Lesions on 68Ga-FAPI-PSMA PET/CT [Срок оценки: 1-4 hours after 68Ga-FAPI-PSMA injection]
  • Mean Standardized Uptake Value (SUVmean) of Normal Organs on 68Ga-FAPI-PSMA PET/CT [Срок оценки: 1 to 4 hours after 68Ga-FAPI-PSMA injection]
  • Number of Metastatic Lesions Detected by 68Ga-FAPI-PSMA PET/CT [Срок оценки: From the date of 68Ga-FAPI-PSMA PET/CT imaging to completion of reference-standard assessment, up to 2 months]

Критерии участия

Критерии включения

  • Age 18-75 years
  • Patients with suspected or confirmed solid tumors (e.g., prostate cancer, hepatocellular carcinoma, ovarian cancer, or endometrial cancer)
  • Patients scheduled to undergo tumor biopsy or surgical treatment within 2 months
  • ECOG performance status of 0 or 1
  • Expected survival of at least 12 weeks
  • Adequate hematologic and organ function:
  • White blood cell count ≥ 4.0 × 10\^9/L or neutrophils ≥ 1.5 × 10\^9/L
  • Platelet count ≥ 100 × 10\^9/L
  • Hemoglobin ≥ 90 g/L
  • Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
  • ALT/AST ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases)
  • Creatinine ≤ 1.5 × ULN
  • At least one measurable lesion according to RECIST 1.1 criteria
  • Ability to understand the study procedures and willingness to sign written informed consent

Критерии исключения

  • Severe hepatic or renal dysfunction
  • Inability to remain in a supine position for approximately 30 minutes during PET/CT scanning
  • Refusal or inability to participate in the clinical study
  • Claustrophobia or severe psychiatric disorders that would interfere with imaging procedures
  • Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07639801 · 2023KT107-ZY02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗