2023-509860-47-00招募中2 期
Multimodal Imaging with FAPI-PET/MRI in Breast Carcinoma-In-Situ for Detection of occult Invasive cancer (MI-CISDIR)
Universitaet Muenster2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年4月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Sensitivity based on blinded readers‘ PET/MRI visual assessment score
研究概览
简要总结
Evaluation of feasibility of detection of occult invasive cancer in diagnosed DCIS of [68Ga]Ga-FAPI-46 breast PET/MRI
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed DCIS with extent in mammography, MRI or ultrasound suspected to range > 4 cm
- •Planned DCIS resection (breast conserving or mastectomy) as per guideline recommendation
- •Age ≥ 18 years
- •Written informed consent
- •For women of childbearing potential: confirmed menstrual period (if applicable) and a negative highly sensitive urine or serum pregnancy test
- •Women of childbearing potential (WOCBP) and fertile male patients with partners of childbearing/reproductive potential must agree to use highly effective contraception (Pearl index < 1) when sexually active. This applies for the time period between signing of the informed consent form up to the final trial visit.
排除标准
- •Contraindications for MRI (specific metallic implants, severe claustrophobia, history of anaphylaxis following MRI contrast agent application)
- •GFR < 30 mL/(min∙1.73 m^2)
- •Current pregnancy or pregnancy within 8 weeks before begin of study participation
- •Current nursing or nursing within 8 weeks before begin of study participation
- •Inability to understand the nature, risks, and benefits of the study
- •History of diagnosis of ipsilateral invasive breast cancer
- •Concurrent diagnosis of contralateral invasive cancer, if not curatively treated by surgery > 1 year ago
- •Known hypersensitivity to the active substance or to any of the excipients of the IMP
结局指标
主要结局
Sensitivity based on blinded readers‘ PET/MRI visual assessment score
Sensitivity based on blinded readers‘ PET/MRI visual assessment score
Specificity based on blinded readers‘ PET/MRI visual assessment score
Specificity based on blinded readers‘ PET/MRI visual assessment score
次要结局
- Optimal threshold and area-under-the-curve of receiver-operating- characteristics curve based on tumor-to-background ratio of SUVmax (60-75min)
- Diagnostic Odds Ratio (DOR) based on Blinded readers’ PET/MRI vs MRI only visual assessment score
- Sensitivity and specificity of lesion MRI diffusion weighted MRI apparent diffusion coefficient (ADC)
- Sensitivity and specificity of the DCE-MRI dynamic feature “Maximal Slope”
- Sensitivity and specificity of the DCE-MRI dynamic feature “Bolus arrival time”
- Sensitivity and specificity of the DCE-MRI pharmacokinetic modeling parameter: Volume transfer constant (KTrans)
- Sensitivity and specificity of the DCE-MRI pharmacokinetic modeling parameter: Fractional plasma volume (Vp)
- Sensitivity and specificity of static PET SUVmax (60-75min)
- Sensitivity and specificity of dynamic PET pharmacokinetic modeling parameter binding potential (BP)
- Number of additional biopsies triggered by PET/MRI visual assessment
- Number of additional biopsies triggered by MRI visual assessment
- Correlation of immunohistopathology FAP visual staining Score with SUVmax (60-75min)
- Adverse events following [68Ga]Ga-FAPI-46 application
研究者
Trial coordinator
Scientific
Universitaet Muenster
研究点 (2)
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