2023-505592-69-00招募中3 期
[18F]F-FAPI PET-CT to Identify Carcinoma of Unknown Primary origin
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)6 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年3月8日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- The proportion of CUP patients in whom the primary tumor is identified by [18F]F-FAPI PET-CT (i.e., the correct detection rate).
研究概览
简要总结
To determine the proportion of CUP patients in whom the primary tumor can be identified by [18F]F-FAPI PET/CT.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Histologically-confirmed metastatic disease without identification of a primary tumor after standard diagnostic work-up, according to the national care pathway for CUP (in Dutch: Regionaal Zorgpad Primaire Tumor Onbekend), which includes at least a [18F]FDG PET-CT.
排除标准
- •Patients with metastasis from a known primary tumor.
- •Inability to lie still on the back for the duration of PET-CT
- •Any (other) condition, disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that may affect the interpretation of the results, or which might contribute substantially to the patient's experience of study burden (such as non-suppressible claustrophobia)
- •Sarcomas, melanomas, germ cell tumors, neuroendocrine tumors and haematological malignancies whose exact site of origin is not established.
- •History of malignancy within 5 years prior to [18F]F-FAPI PET-CT scan, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as adequately treated carcinoma in-situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in-situ, or Stage I uterine cancer.
- •Prior systemic therapy for the treatment of CUP.
- •Radiotherapy prior to [18F]F-FAPI PET-CT. Off note: radiotherapy with palliative intent for symptomatic skeleton lesions is allowed.
- •Impaired renal function, defined as eGFR (MDRD) <25 ml/min/1,73 m
- •An exception can be made in consultation with the treating physician.
- •WHO performance status >2 (Vademecum).
- •Pregnancy/breastfeeding. For the latter, temporary discontinuation may be considered.
- •Known allergic reaction to therapeutic radiopharmaceuticals
结局指标
主要结局
The proportion of CUP patients in whom the primary tumor is identified by [18F]F-FAPI PET-CT (i.e., the correct detection rate).
The proportion of CUP patients in whom the primary tumor is identified by [18F]F-FAPI PET-CT (i.e., the correct detection rate).
次要结局
- Sensitivity, specificity, positive- and negative predictive value of [18F]F-FAPI PET-CT.
研究者
S.E.M. Veldhuijzen van Zanten
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
研究点 (6)
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