NCT06059469招募中2 期
PRISMA: A Single-centre, Prospective Phase II Imaging Study Using PSMA-PET/CT to Assess the Expression of Specific Membrane Antigen (PSMA) in Patients With Progressive Triple-negative Breast Cancer.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Assess PSMA expression in progressive metastatic TNBC patients
研究概览
简要总结
This is a descriptive, prospective, single centre study. This study will assess PSMA expression via the uptake of radiolabelled PSMA-ligand using PET/CT imaging in mTNBC lesions pre-identified on 18F-FDG PET/CT in order to evaluate the feasibility of molecular radionuclide therapy in refractory mTNBC using the Lutetium-177 radiolabelled PSMA.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent in accordance with institutional guidelines and obtained prior to any study procedure
- •Women with ≥ 18 years-old
- •Eastern Cooperative Oncology Group Performance Status of 0 to 2
- •Confirmed diagnosis of progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT (performed within 2 weeks) or Brain MRI in case of progressive brain metastases (performed within 4 weeks) prior to PSMA PET/CT.
- •Radiolabelled PSMA PET/CT has to be performed before the next treatment line initiation
排除标准
- •Pregnant or lactating patients
- •Other active neoplastic disease
- •Treatment by another molecule that is the object of investigation within 30 days
- •Skin only metastatic disease
- •Patients with a significant medical, neuro-psychiatric, or surgical condition, which, in the investigator's opinion, may interfere with completion of the study
结局指标
主要结局
Assess PSMA expression in progressive metastatic TNBC patients
时间窗: once at baseline prior to the start of the new anti cancer treatment
uptake of radiolabelled PSMA-ligand in patients with mTNBC on PET/CT images.
次要结局
- Assess the concordance between lesions visualized on PSMA PET/CT and 18F-FDG PET/CT images (or brain MRI in case of brain metastases).(once at baseline prior to the start of the new anti cancer treatment)
研究者
研究点 (1)
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