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Набор скоро начнётся NCT06792097

Ga-68 Dolacga PET Scan in HCC Under RFA

— Наблюдательное Hepatocellular Carcinoma (HCC) Radiofrequency Ablation PET Scan Computed Tomography

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: Ga-68 Dolacga PET scan.
Кому может быть актуально
Состояния в реестре: Hepatocellular Carcinoma (HCC), Radiofrequency Ablation, PET Scan, Computed Tomography. Базовые параметры: 18 лет — 80 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

The Role of Ga-68 Dolacga PET Scan in Patients With Hepatocellular Carcinoma Under Radiofrequency Ablation

Обзор

This study aims to investigate the use of Ga-68 Dolacga PET scan technology to assess treatment response and liver function changes in patients of early-stage liver cancer receiving RFA. The main questions it aims to answer are: 1. How to assess treatment response and liver function changes in hepatocellular carcinoma patients undergo RFA via Ga-68 Dolacga PET scan? 2. Compared with computed tomography (CT) scans, how effective is Ga-68 Dolacga PET scan for treatment response assessment? 3. What is the correlation between Ga-68 Dolacga PET scan findings and patient treatment outcomes by tracking liver function and tumor recurrence after RFA? Participants will: 1. Undergo Ga-68 Dolacga PET scans and computed tomography before and one month after RFA treatment, followed by monitoring every three months thereafter. 2. Total liver functional volume and residual liver functional volume are obtained from Ga-68 Dolacga PET scan

Подробное описание

This study aims to investigate the use of Ga-68 Dolacga PET scan technology to assess treatment response and liver function changes in patients of early-stage liver cancer receiving RFA. This study also compares the results of Ga-68 Dolacga PET scans with computed tomography (CT) scans and evaluate the correlation between Ga-68 Dolacga PET scan findings and patient treatment outcomes by tracking liver function and tumor recurrence after RFA.

This study adopts a prospective clinical trial design, enrolling patients with early-stage liver cancer and undergoing RFA treatment. Clinical data, laboratory results, serum, biopsy tissues for pathology and relevant imaging findings are collected for analysis. Participants undergo Ga-68 Dolacga PET scans and CT before and one month after RFA treatment, followed by monitoring every three months thereafter. Quantitative analysis utilizes region of interest techniques to measure standardized uptake values (SUV). Total liver functional volume and residual liver functional volume are obtained from Ga-68 Dolacga PET scan injection dose percentages and SUV values. Changes in liver storage capacity as determined by Ga-68 Dolacga PET scans are evaluated and correlated with traditional laboratory liver function tests and imaging evaluations.

Вмешательства

  • Диагностический тест Ga-68 Dolacga PET scan
    Contrast Name: Nuclear Medicine Dolacga (Lyophilized product for the preparation of gallium Ga68 Dolacga injection). Active Ingredient, Dosage, Route: NOTA-Hexa lactoside (INER038), 40 micrograms, IV injection. PET Imaging Schedule: Before radiofrequency ablation therapy, one month after ablation therapy, and follow-up every three months thereafter.

Первичные конечные точки

  • Patient liver reserve capacity before and after radiofrequency ablation therapy [Срок оценки: 2 years]

Критерии участия

Критерии включения

  • Patients with hepatocellular carcinoma (BCLC stage 0 and stage A) eligible for radiofrequency ablation (RFA) treatment exhibit the following characteristics:
  • A single liver tumor, ≤ 2 cm, classified as BCLC stage 0 (very early stage).
  • Tumors ≤ 3 in number, each ≤ 3 cm, or a single tumor ≤ 5 cm, classified as BCLC stage A (early stage) liver cancer.
  • ECOG performance status of 0.
  • Age ≥ 18 years.

Критерии исключения

  • Intermediate (BCLC B stage) and advanced (BCLC C stage) liver cancer patients:
  • A single tumor > 5 cm, or multiple tumors > 3 cm.
  • Diffuse hepatocellular carcinoma.
  • Vascular invasion (e.g., portal vein obstruction).
  • Extrahepatic tumor spread.
  • Early-stage liver cancer (BCLC A stage):
  • Contraindications for radiofrequency ablation (RFA).
  • Target lesions previously treated with local therapies, including surgical resection, percutaneous ethanol injection (PEI), or liver transplantation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06792097 · 202409045MIND

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗