Exploring the Clinical Value of RT01-89Zr PET Imaging in Solid Tumors

Обзор

RT01-89Zr is a TF-targeting radiopharmaceutical diagnostic agent. This trial aims to evaluate the safety, biodistribution, dosimetry, and imaging characteristics of RT01-89Zr as a PET/CT tracer in patients with malignant solid tumors that highly express the TF target.

Вмешательства

• Препарат RT01-89Zr
  Intravenous injection of RT01-89Zr with a dosage of 1-2 mCi

Первичные конечные точки

• Safety evaluation [Срок оценки: Within 21 days after administration]

Вторичные конечные точки (8)

• Biological distribution [Срок оценки: through study completion, an average of 3 months]
• Radiation Dosimetry [Срок оценки: through study completion, an average of 3 months]
• Visual Analysis [Срок оценки: through study completion, an average of 3 months]
• Semi-quantitative analysis [Срок оценки: through study completion, an average of 3 months]
• Probe Targeting Performance Analysis [Срок оценки: through study completion, an average of 3 months]
• Biological distribution [Срок оценки: through study completion, an average of 3 months]
• Biological distribution [Срок оценки: through study completion, an average of 3 months]
• Semi-quantitative analysis [Срок оценки: through study completion, an average of 3 months]

Критерии участия

Критерии включения

• Patients of either gender, ages 18-75 (including 18 and 75);
• ECOG Performance Status: 0 or 1;
• Confirmed as a solid tumor by histopathology or cytology;
• At least one primary or metastatic lesion confirmed by conventional imaging；
• During the screening period, tumor tissue samples (either archived previously or freshly biopsied) can be provided, with positive target expression of more than 1%;
• Voluntarily participate in this study and sign a written informed consent form, agree to comply with the research procedures, and cooperate throughout the entire research process;
• Women of childbearing potential must have a negative pregnancy test result. If the patient is of childbearing potential, she must agree to abstain from sexual activity or use highly effective contraception from the time of signing the informed consent until 3 months after the administration of the investigational drug;

Критерии исключения

• Patients who are unable to complete a PET/CT scan (including those who cannot lie flat, have claustrophobia, or have fear of radiation, etc.);
• Those who have received radiopharmaceuticals before administration and whose discontinuation duration does not exceed 5 half-lives;
• Participants who have participated in other clinical trials within the past 3 months (except for clinical trials of investigational drugs discontinued for more than 5 half-lives, and assessed by the investigator as having no impact on endpoint evaluation and participant safety), or who plan to participate during the trial;
• Acute systemic diseases and electrolyte disorders;
• Patients known to be allergic to the RT01 contrast agent or synthetic excipients;
• Researchers believe that patients with poor adherence;
• Patients who are pregnant or breastfeeding;
• Other factors that render the patient unsuitable for trial participation..

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

Китай · 1 центр

• Affiliated Hospital of Jiangnan University — Wuxi

Идентификаторы

NCT: NCT07505069 · QM-RT01-2551

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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