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临床试验/NCT04040166
NCT04040166已完成不适用

PET/MR of the Carotid Arteries With 68Ga DOTATATE in Patients Following Head and Neck Radiation Therapy and at Risk of Cerebrovascular Events

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年8月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Validity of PET/MRI with 68Ga DOTATATE of carotid arteries

研究概览

简要总结

The improvement of comprehensive multi-modality treatment and radiotherapy (RT) technology has resulted in an improved survival rate of head and neck malignancies within recent decades. As survival increases, late toxicity from cancer therapy becomes a larger burden. Radiation induced vascular injury following RT is a recognized complication of radiotherapy. Diagnosis of vascular changes predominately relies on non-invasive imaging techniques. Doppler ultrasound assessment has been proven as a good indicator of diffuse atherosclerotic disease and a significant predictor of future vascular events. New opportunities are provided by the recent introduction of the hybrid PET/MRI scanners for investigating the synergistic effect of these two modalities without the challenge of image co-registration. It has been shown that the PET system integrated with the MRI scanner performs the same as the PET portion of a PET/CT for various cancers and cardiovascular indications. MRI allows better delineation of the carotid artery and atherosclerotic plaque when compared with CT due to the superior soft tissue contrast. The PET/MRI system acquires the PET and MRI simultaneously allowing for perfect alignment between the 2 sets of images, when compared with the sequential acquisition in PET/CT where minor head movements can cause misalignment. There is evidence in the literature that 68-Ga DOTA-TATE PET-imaging can serve as a surrogate marker for evidence of invasion into the vessel wall and thereby possibly detects early, developing atherosclerotic plaque. Thus, combined PET and MR with 68-Ga DOTA-TATE should be a promising imaging tool to screen and characterize patients at risk for radiation induced carotid injury.

In this study, DOTATATE-PET/MR will be performed in up to 60 patients with a history of radiation therapy for head and neck squamous cell carcinoma over 2 years.

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
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • previously treated with radiation for head and neck malignancy;
  • Age Group: ≥30 years;
  • Patients who have no contraindications to PET/MRI;
  • No allergy to contrast agents.

排除标准

  • Pregnant females;
  • Age group: < 30 years;
  • Allergy to MR contrast agents;
  • Pacemakers/ICD/Claustrophobic patients.

结局指标

主要结局

Validity of PET/MRI with 68Ga DOTATATE of carotid arteries

时间窗: complete of enrollment, an average of two years

Macrophage activity detected by 68Ga DOTATATE PET/MRI of carotid arteries in patients at risk for vascular events post radiation of head and neck squamous cell carcinoma.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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