[⁶⁸Ga]Ga-FAP-2286 PET/CT for Staging and Restaging Patients With Newly Diagnosed Primary Breast Cancer: a Phase II Study (FAPILOUS)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 65
- 主要终点
- Number of patients with nodal and distant metastases detected by [⁶⁸Ga]Ga-FAP-2286 PET/CT at baseline (pre-treatment staging)
研究概览
简要总结
This study aims to evaluate the clinical utility of [68Ga]Ga-FAP-2268 PET/CT for disease staging and assessment in patients with high-risk primary breast cancer. By targeting fibroblast activation protein (FAP), this novel imaging approach may offer improved tumor visualization compared to conventional imaging, which may help improve treatment planning.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Male and females ≥ 18 years
- •Biopsy-verified newly diagnosed 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 the conduct of the scan due to any reason ( e.g., claustrophobia or inability to lie still for entire imaging time)
- •Ongoing oncological treatment for another cancer
- •History of allergic reactions / hypersensitivity attributed to [⁶⁸Ga]Ga-FAP-2286.
研究组 & 干预措施
68Ga-FAP-2286 PET/CT Imaging
Patients undergo intravenous administration (200 MBq) of 68Ga-FAP-2286 followed by PET/CT imaging for staging of high-risk primary breast cancer. A baseline scan is performed prior to initiation of therapy. Patients receiving neoadjuvant chemotherapy undergo an additional scan prior to surgery.
干预措施: 68Ga-FAP-2286 (Drug)
结局指标
主要结局
Number of patients with nodal and distant metastases detected by [⁶⁸Ga]Ga-FAP-2286 PET/CT at baseline (pre-treatment staging)
时间窗: Baseline (pre-treatment). Inclusion period 1 year.
Nodal and distant metastases will be identified on a per-patient and per-lesion basis using \[⁶⁸Ga\]Ga-FAP-2286 PET/CT in 65 patients undergoing baseline staging. PET/CT images will be read blinded. The reference standard is histopathology where available; if histopathology is not available, a composite of clinical and imaging follow-up will be used. Sensitivity and specificity with 95% confidence intervals will be calculated per patient and per lesion.
Concordance of [⁶⁸Ga]Ga-FAP-2286 PET/CT with surgical pathology for axillary lymph node status after neoadjuvant therapy (restaging)
时间窗: Post-therapy/ pre-surgery scan, about 6 month after baseline scan.
In approximately 50 patients undergoing post-neoadjuvant therapy PET/CT prior to surgery, axillary lymph node status will be classified as (a) uptake on PET/CT with histologically confirmed residual disease, or (b) no uptake on PET/CT with pathological complete response (pCR). PET/CT images will be read blinded, with surgical pathology as the gold standard. Concordance (proportion correctly classified) and appropriate concordance statistics will be calculated.
次要结局
- Number of patients with TNM stage or MDT treatment decision changes after [⁶⁸Ga]Ga-FAP-2286 PET/CT(Baseline (pre-PET/CT) and up to 7 days post-PET/CT at MDT review)
- Inter-reader agreement of [⁶⁸Ga]Ga-FAP-2286 PET/CT lesion detection, BI-RADS-like scoring, and SUV/TBR quantification(Baseline (initial reading) and up to 18 months post-baseline for blinded second reading)
- Incidence, severity, and causality of AEs, SAEs, and SUSARs after [⁶⁸Ga]Ga-FAP-2286 administration(From tracer injection to 48 hours post-injection)
- Lesion-level [⁶⁸Ga]Ga-FAP-2286 uptake patterns (SUVmax, SUVmean, LBR) across tumor subtypes and anatomical sites(Baseline and up to approximately 6 months post-baseline.)
- Frequency, type, and clinical impact of incidental findings on [⁶⁸Ga]Ga-FAP-2286 PET/CT(Baseline and up to approximately 6 months post-baseline (Pre-surgery, for patients receiving NACT))