Novel Ga68-PSMA PET/CT-tracer to Differentiate Between Radiation Necrosis and Tumor Progression in Stereotactic Irradiated Brain Metastases: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Tracer Uptake (SUVpeak) on PSMA PET/CT in Brain Lesions
研究概览
简要总结
This study aims to evaluate the diagnostic potential of 68-Gallium PSMA-PET/CT in stereotactic irradiated brain metastases from non-small cell lung cancer, melanoma and breast cancer.
详细描述
This prospective phase II diagnostic feasibility study investigates the diagnostic potential of 68-Gallium PSMA-PET/CT in stereotactic irradiated brain metastases from non-small cell lung cancer, melanoma and breast cancer.
Participants will be enrolled in three predefined cohorts per primary tumor type:
- newly diagnosed brain metastases,
- definite radiation necrosis, and
- diagnostic dilemma after radiotherapy.
The goals of this study are:
1. Evaluating PSMA expression using Ga68-PSMA PET/CT in brain metastases of NSCLC, breast cancer and melanoma patients eligible for stereotactic radiotherapy (SRT) or surgery. 2. Evaluating PSMA expression using Ga68-PSMA PET/CT in patients with definite radiation necrosis. 3. Evaluating the use of Ga68-PSMA PET/CT to differentiate progressive brain metastases of NSCLC, breast cancer and/ or melanoma from radiation necrosis by quantifying PSMA activity.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For all groups:
- •Written informed consent
- •Age ≥ 18 years old
- •WHO PS 0-3
- •Measurable lesion ≥10mm according to RANO BM
- •For brain metastases groups:
- •- newly diagnosed brain metastases from either NSCLC (group 1) or melanoma (group 2) or breast cancer (group 7).
- •For radiation necrosis groups:
- •- Brain lesion at the location of a formerly brain metastases that has been treated with SRT (> 9 months ago), with the definite diagnosis of radiation necrosis at the location of formerly SRT-treated brain metastases of NSCLC (group 3), melanoma (group 4) and/ or breast cancer (group 8).
- •For diagnostic dilemma groups:
- •- Brain lesion at the location of a formerly brain metastases with a diagnostic dilemma of radiation necrosis and recurrent brain metastases of NSCLC (group 5), melanoma (group 6) and/ or breast cancer (group 9).
排除标准
- •For all groups:
- •Known allergy to Ga68-PSMA
- •Epileptic seizure less than 7 days before Ga68-PSMA PET/CT scan
- •Life expectancy less than 3 months
- •Patients with known prostate carcinoma
- •Pregnancy
研究组 & 干预措施
Additional novel PET/CT
Additional novel PET/CT scan compared to standard-of-care
干预措施: 86-Gallium PSMA PET/CT (Diagnostic Test)
结局指标
主要结局
Tracer Uptake (SUVpeak) on PSMA PET/CT in Brain Lesions
时间窗: Baseline
Quantitative tracer uptake (SUVpeak) measured on PSMA PET/CT in lesions classified as brain metastases, radiation necrosis, or diagnostic dilemma lesions.
次要结局
- Qualitative Visual Assessment of Brain Lesions on PSMA PET/CT(Baseline)
- Overall Visual Classification of Brain Lesions on PSMA PET/CT(Baseline)