2025-521324-29-00招募中2 期
[⁶⁸Ga]Ga-HKG301 PET/CT for staging and restaging patients with primary breast cancer: a phase II study (FAPILOUS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Sensitivity, specificity, predictive values, and accuracy for primary staging and restaging breast cancer with [⁶⁸Ga]Ga-HKG301 PET/CT
研究概览
简要总结
The main objective is to evaluate the efficacy of [⁶⁸Ga]Ga-HKG301 PET/CT in staging and restaging patients with newly diagnosed breast cancer.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male and females ≥18 years
- •Biopsy-verified newly diagnosed primary breast cancer
- •Can read and understand Danish
- •Capable of providing written and informed consent
- •Undergoing a routine [¹⁸F]FDG PET/CT scan as part of the clinical standard diagnostic workup
排除标准
- •Pregnant or lactating women
- •Not able to participate in scan
- •Ongoing oncological treatment for another cancer
- •History of allergic reactions / hypersensitivity attributed to [⁶⁸Ga]Ga-HKG301
研究组 & 干预措施
AAA514
Test
干预措施: AAA514 (Drug)
结局指标
主要结局
Sensitivity, specificity, predictive values, and accuracy for primary staging and restaging breast cancer with [⁶⁸Ga]Ga-HKG301 PET/CT
Sensitivity, specificity, predictive values, and accuracy for primary staging and restaging breast cancer with [⁶⁸Ga]Ga-HKG301 PET/CT
次要结局
- The correlation between the response measures observed on [⁶⁸Ga]Ga-HKG301 PET/CT and the histopathological response
- The influence of [⁶⁸Ga]Ga-HKG301 PET/CT on stage migration, alterations in treatment decisions, and incidental findings
- Evaluate safety and tolerability of [⁶⁸Ga]Ga-HKG301
研究者
Sara Dahlsgaard-Wallenius
Scientific
Odense University Hospital
研究点 (1)
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