2025-524874-41-00招募中2 期
Paediatric sarcoma, hybrid imaging & FAPI – Raising the diagnostic standard for paediatric sarcoma patients combining novel radiotracer FAPI and whole-body PET/MRI
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The ability of the nuclear medicine physician and the radiologist to accurately detect malignancy in [68Ga]Ga-FAPI-46 WB PET/MRI vs. SOC imaging.
研究概览
简要总结
The aim of the study is to evaluate [68Ga]Ga-FAPI-46 WB PET/MRI as a diagnostic tool to improve tumour lesion evaluation at primary staging, during treatment control and at relapse in paediatric sarcoma patients.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •<18 years old
- •Referred for evaluation of any type of sarcoma at the Dept. of Paediatric and Adolescent Medicine, Copenhagen University Hospital, Rigshospitalet
- •Participant and/or legal guardian must be able to read and understand the PIS in Danish and/or English to sign the ICF.
排除标准
- •Pregnancy or lactation
- •Not considered able to cooperate to the trial imaging procedures without sedation by the referral department
- •Severe claustrophobia or any other positive outcomes on the MRI safety checklist
- •History of allergic reaction due to compounds similar to the chemical composition of [68Ga]Ga-FAPI-46
研究组 & 干预措施
Fluor-18-FDG, 400 MBq-210 GBq, injektionsvreske Fludeoxyglucose (18F)
Comparator
干预措施: Fluor-18-FDG, 400 MBq-210 GBq, injektionsvreske Fludeoxyglucose (18F) (Drug)
68GA-FAPI-46
Test
干预措施: 68GA-FAPI-46 (Drug)
结局指标
主要结局
The ability of the nuclear medicine physician and the radiologist to accurately detect malignancy in [68Ga]Ga-FAPI-46 WB PET/MRI vs. SOC imaging.
The ability of the nuclear medicine physician and the radiologist to accurately detect malignancy in [68Ga]Ga-FAPI-46 WB PET/MRI vs. SOC imaging.
次要结局
- Correlation of IHC of the FAP-antigen in tumour lesions and tumour FAP-expression using the radioactive tracer [68Ga]Ga-FAPI-46
- Evaluation of patient and/or parent(s’) and experiences.
- Evaluation of the technical feasibility of implementation in clinical practice
研究者
Flemming Littrup Andersen
Scientific
Rigshospitalet
研究点 (1)
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