NCT05175404已完成2 期
Use of 18F-PSMA-11 PET for Detection of Lesions in Iodine Refractory Thyroid Cancers
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Demonstrate uptake of 18F-PSMA-11 in RAI-RTC
研究概览
简要总结
Determine the diagnostic value of 18F-PSMA-11 in patients with iodine refractory thyroid cancer.
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
- 否
入选标准
- •Patient is 18 years or older.
- •Signed Informed Consent.
- •Subject is diagnosed with a histologically confirmed differentiated thyroid carcinoma, that is considered RAI refractory. There is evidence of persisting or recurrent disease, based on serum thyroglobulin levels and/or medical imaging.
- •Subject should have a routine clinical 18F-FDG PET/CT performed within two months prior to the study scan.
- •Female patients should be either post-menopausal, surgically sterile, or using highly effective contraceptives (methods that can achieve a failure rate of less than 1%: combined hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence).
排除标准
- •Patient has a known other active malignancy.
- •Subject is potentially pregnant (urinary test can be performed in case of doubt) or breastfeeding.
- •Patient is mentally or legally incapacitated.
结局指标
主要结局
Demonstrate uptake of 18F-PSMA-11 in RAI-RTC
时间窗: 60 minutes +- 5 minutes after injection 18F-PSMA-11
Confirmation in PET-scan that lesions in RAI-RTC show uptake of 18F-PSMA-11, above background activity in the bloodpool.
次要结局
- Compare uptake of 18F-PSMA-11 in these patients to the uptake of 18F-FDG, on a lesion basis.(60 minutes +- 5 minutes after injection 18F-PSMA-11)
- Evaluate the sufficiency of uptake of 18F-PSMA-11 to consider therapy with 177Lu-PSMA in a subset of patients(60 minutes +- 5 minutes after injection 18F-PSMA-11)
- Compare the histological expression of PSMA on already available tumor samples with the uptake of lesions on PSMA PET.(60 minutes +- 5 minutes after injection 18F-PSMA-11)
- Perform a semi-quantitative analysis of radiotracer uptake in lesions.(60 minutes +- 5 minutes after injection 18F-PSMA-11)
- Perform a lesion detection rate analysis on organ level.(60 minutes +- 5 minutes after injection 18F-PSMA-11)
- Analyse the correlation between the serum level of PSMA and the uptake on PSMA PET(60 minutes +- 5 minutes after injection 18F-PSMA-11)
- Compare the histological expression of PSMA on already available tumor samples with the serum level of PSMA.(Within 1 year)
研究者
研究点 (1)
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