NCT06145399撤回早期 1 期
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging In Patients Advanced Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 主要终点
- Number of lesions that correlate 18F-FDHT uptake with IHC expression of AR
研究概览
简要总结
The purpose of this study is to see whether 18F-FDHT PET/MRI scans are an effective way of identifying AR-positive breast cancer.
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
- •Age ≥ 18 years
- •ECOG performance score of 0-2
- •Signed informed consent
- •Histologically confirmed AR+ breast cancer
- •All participants under consideration for enrollment will have their tumor specimen tested centrally at MSK; nuclear AR staining ≥ 1% will be considered positive.
- •Progressive metastatic breast cancer manifested as increase in evaluable disease OR the appearance of new sites of disease since the date of the last imaging study performed and under consideration for AR-targeted therapy
- •Planning to undergo treatment with agents targeting the antiandrogen signaling pathway on a clinical trial
排除标准
- •Life expectancy < 3 months
- •Pregnancy or lactation
- •Participants who cannot undergo scanning because of
- •weight limits
- •devices or implants that are not MRI safe
- •allergies to contrast materials
- •CNS only disease on recent imaging
研究组 & 干预措施
Participants with Breast Cancer
Experimental
Participants with histologically confirmed AR+ breast cancer
干预措施: 18F-FDG PET/CT (Diagnostic Test)
Participants with Breast Cancer
Experimental
Participants with histologically confirmed AR+ breast cancer
干预措施: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging (Diagnostic Test)
Participants with Breast Cancer
Experimental
Participants with histologically confirmed AR+ breast cancer
干预措施: 18F-FDHT (Drug)
结局指标
主要结局
Number of lesions that correlate 18F-FDHT uptake with IHC expression of AR
时间窗: 8 weeks post treatment
The primary objective is to correlate 18F-FDHT uptake with IHC expression of AR as in selected lesions.
次要结局
未报告次要终点
研究者
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