AI-based Low Dose CBCT Reconstruction for Clinical Application

Официальное название

AI-based Low Dose CBCT Reconstruction for Lung Puncture Guidance: A Multicenter Randomized Controlled Study

Обзор

The goal of this clinical trial is to learn if AI-based low dose CBCT reconstructed images can guide lung puncture effectively. The main questions it aims to answer are: 1. Does the AI-based low dose CBCT reconstruction model reconstruct high quality images? 2. Is it possible that low-dose CBCT reconstructed images can guide lung puncture procedures without compromising the efficiency of the procedure? Researchers will compare AI-based low dose CBCT reconstructed images to a placebo (conventional CBCT images) to see if AI-based low dose CBCT reconstructed image can guide lung puncture procedures without compromising the efficiency of the procedure. Participants will: 1. Undergo lung puncture under AI-based low dose CBCT reconstructed images guidance or under conventional CBCT images 2. Be followed up for 1 week postoperative to obtain patient complications

Вмешательства

• Другое AI-based low dose CBCT reconstructed images system
  Participants in the experimental group undergo AI-based low dose (radiation dose is 1/6th of the dose used in the clinic) CBCT reconstructed images guided lung puncture procedures.
• Другое Conventional CBCT images system
  Participants in the experimental group undergo conventional CBCT images guided lung puncture procedures.

Первичные конечные точки

• Number of puncture needles of participants undergoing percutaneous lung puncture procedures. [Срок оценки: From enrollment to the end of the lung puncture procedure.]

Вторичные конечные точки (2)

• Radiation Dose [Срок оценки: From enrollment to the end of the lung puncture procedure.]
• Intraoperative and postoperative complications of participants undergoing lung puncture procedures [Срок оценки: From enrollment to the end of the lung puncture procedure at 1 week.]

Критерии участия

Критерии включения

• Participants who require CBCT-guided precutaneous lung puncture (PLP) and meet the clinical indications for the procedure.
• Participants whose physical condition is suitable for PLP.
• Participants are willing to sign informed consent.

Критерии исключения

• Participants have metallic implants in the body, which severely affects the image quality.
• Participants are pregnant or breastfeeding.
• Participants are unwilling or unable to sign informed consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Китай · 3 центра

• Wuhan Union Hospital — Ухань
• Wuhan Union Jinyinhu Hospital — Ухань
• Wuhan Union West Hospital — Ухань

Публикации

• Zhao H, Xu Z, Chen L, Wu L, Cui Z, Ma J, Sun T, Lei Y, Wang N, Hu H, Tan Y, Lu W, Yang W, Liao K, Teng G, Liang X, Li Y, Feng C, Nie T, Han X, Xiang D, Majoie CBLM, van Zwam WH, van der Lugt A, van der Sluijs PM, van Walsum T, Feng Y, Liu G, Huang Y, Liu W, Kan X, Su R, Zhang W, Wang X, Zheng C. Large-scale pretrained frame generative model enables real-time low-dose DSA imaging: An AI system deve PMID 39163857

Идентификаторы

NCT: NCT06831617 · AI guidance-Lung 001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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