68Ga-PSMA-PET/CT Imaging for Locally Advanced, Recurrent and Metastatic Adenoid Cystic Carcinoma or Salivary Duct Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- uptake of 68Ga-PSMA in ACC and SDC
研究概览
简要总结
Diagnostic study which evaluates the level of PSMA expression in patients with locally advanced, recurrent and/or metastatic ACC/SDC of ≥18 years old with 68Ga-PSMA-PET/CT imaging in order to establish whether these patients are eligible for 177Lu-PSMA therapy
详细描述
Rationale: PSMA is a transmembrane protein, which is expressed on prostate cancers cells, ACC and other malignancies. In prostate cancer, distant metastases can be visualized sensitively and non-invasively with 68Ga-PSMA-PET/CT scans and if the uptake of 68Ga is high enough, patients can be treated with the β-emitting radionuclide 177Lu-PSMA. In the current study, we will evaluate the uptake of 68Ga-PSMA by performing 68Ga-PSMA-PET/CT scans in advanced ACC and SDC patients. If the uptake is high enough, this will form the rationale for a therapeutic study with 177Lu-PSMA in ACC and SDC.
Objective
The primary objective is to evaluate the uptake of 68Ga-PSMA in locally advanced, recurrent and metastatic ACC/SDC by performing 68Ga-PSMA-PET/CT scans. The secondary objectives are to calculate the SUV tumor-to-background ratio and tumor-to-'healthy salivary gland tissue' ratio. To correlate the SUV to the degree of immunohistochemical PSMA expression of the primary tumor on archival tissue, and to establish whether new metastatic lesions are found by 68GA-PSMA-PET/CT imaging.
Study design: Diagnostic study which evaluates the level of PSMA expression in ACC/SDC patients with 68Ga-PSMA-PET/CT imaging in order to establish whether these patients are eligible for 177Lu-PSMA therapy.
Study population: Patients with locally advanced, recurrent or metastatic ACC/SDC of ≥18 years old.
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
- •locally advanced, recurrent or metastatic ACC/SDC
- •Age ≥ 18 years old
- •Ability to provide written informed consent
排除标准
- •Contra-indication for PET imaging
- •Pregnancy
- •Breast feeding
- •Severe claustrophobia
- •Impaired renal function: MDRD <30 ml/min/1,73 m2
- •Impaired liver function: AST and ALT ≥ 2.5 x ULN (≥5 x ULN for patients with liver metastases)
研究组 & 干预措施
PSMA-PET/CT scan
PSMA-PET/CT imaging in advanced ACC/SDC
干预措施: PSMA-PET/CT scan (Diagnostic Test)
结局指标
主要结局
uptake of 68Ga-PSMA in ACC and SDC
时间窗: 0 days
To evaluate the uptake of 68Ga-PSMA in locally advanced, recurrent and metastatic ACC/SDC by performing 68Ga-PSMA-PET/CT scans
次要结局
- SUV of 68Ga-PSMA in the background(0 days)
- new metastases(0 days)
- SUV of 68Ga-PSMA in ACC/SDC tumors(0 days)
- correlation of SUV and IHC PSMA-staining(0 days)
研究者
Carla van Herpen
MD, PhD
Radboud University Medical Center