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临床试验/NCT06246838
NCT06246838招募中不适用

68Ga PET/CT Versus 99mTc SPECT/CT for Lung Perfusion and Ventilation Scintigraphy; a Technical and Practical Feasibility Study

UMC Utrecht2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
UMC Utrecht
入组人数
20
试验地点
2
主要终点
Quantitative assessment of V/Q PET/CT

研究概览

简要总结

Lung perfusion scintigraphy with 99mTc-MAA and ventilation scintigraphy with Technegas (V/Q SPECT/CT) has been the cornerstone for the detection of pulmonary embolisms (PE) for many decades. In last two decades after the introduction of pulmonary CTA, general PE detection has shifted towards CTA and V/Q SPECT/CT has become the modality of choice for specific patient populations (iodine contrast allergy, poor kidney function, pregnancy, etc.) or indications (pre-operative risk stratification, chronic embolism detection, pulmonary hypertension). V/Q SPECT/CT acquisition is performed on a gamma camera, but this technique has distinct challenges and/or disadvantages. A potential alternative is the nowadays broadly available. 68Ga as a positron emitter allows PET/CT imaging. Replacing 99mTc with 68Ga in both MAA and aerosol suspension is easy and requires no modifications. However, 68Ga-V/Q with PET/CT will resolve many of the disadvantages of V/Q SPECT/CT. International studies have proven safety and feasibility of replacing 99mTc with 68Ga and preliminary work by international colleagues and our institute have shown validated preparations of the radiopharmaceuticals. However, in our institution, clinical translation is hampered by lack of data on technical acquisition parameters for our scanners. The aim of this small study is to get more insights into technical parameters for image acquisition, logistical feasibility of V/Q PET/CT, and confirm preliminary non-inferiority of this new technique over the current clinical standard (V/Q SPECT/CT).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult ≥18 years and declared competent
  • Provided written informed consent
  • Referred to the Nuclear Medicine Department for a conventional V/Q-SPECT/CT
  • Indication for conventional V/Q-SPECT/CT includes known or suspected pulmonary embolism

排除标准

  • Pregnancy

结局指标

主要结局

Quantitative assessment of V/Q PET/CT

时间窗: Study participation is maximum 1 week.

Quantitative assessment of different image acquisition parameters for V/Q PET/CT, by comparison semi-quantitative measurements of V/Q PET (e.g. signal-noise ratio's, etc.).

Qualitative assessment of V/Q-PET/CT

时间窗: Study participation is maximum 1 week.

Qualitative assessment of different image acquisition parameters for V/Q PET/CT, as determined by blinded assessment by experienced nuclear medicine physicians in a 5-point Likert scale of V/Q PET (compared to the clinical reference standard V/Q SPECT).

次要结局

未报告次要终点

研究者

发起方
UMC Utrecht
申办方类型
Other
责任方
Principal Investigator
主要研究者

Arthur Braat

Dr. A.J.A.T. Braat

UMC Utrecht

研究点 (2)

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