Piloting 18F-FAPI PET/MRI for Applications in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Diagnostic accuracy of 18F-FAPI-PET/MRI in detection of breast cancer lesions
研究概览
简要总结
Breast cancer is the most common type of cancer in Norwegian women, with 4,224 new cases in 2022. More precise diagnosis are expected to result in more accurate assessment of treatment effect, and to contribute to both providing better treatment and reducing overtreatment. Fibroblast activating protein (FAP) is expressed in the tumor stroma of 90% of all epithelial-based tumors, including breast tumors. Inhibitors for this protein (FAPI) has been developed for use as radioactive tracers. Breast tumors of various histopathological types, and local metastatic lymph nodes, have shown high uptake for such tracers. The main aim of this project is to establish 18F-FAPI PET/MRI for use in breast cancer in a wide range of disease stages. We will evaluate how FAPI PET/MRI correlates with histopathological assessment, the method's ability to grade tumors - including assessment of treatment - compared to CT, scintigraphy and FDG PET/CT, and ability to detect local recurrence.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria are accepting to undergo 18F-FAPI PET/MRI examinations and
- •diagnosed with local invasive breast cancer,
- •scheduled for neoadjuvant therapy as primary treatment,
- •has recurrent or new breast cancer, or
- •scheduled for neoadjuvant therapy as primary treatment with FDG-PET/CT applied for staging.
排除标准
- •other primary malignancies than breast cancer, renal insufficiency or know allergy towards contrast agents, and MR incompatible implants.
研究组 & 干预措施
FAPI-PET/MRI
The patients will be injected 2 MBq/kg 18F-FAPI, prior to PET/MRI acquisition
干预措施: FAPI PET/MR (Diagnostic Test)
结局指标
主要结局
Diagnostic accuracy of 18F-FAPI-PET/MRI in detection of breast cancer lesions
时间窗: Baseline
Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of 18F-FAPI-PET/MRI in detecting breast cancer lesions, including primary tumors, regional lymph node metastases, distant metastases, and local/distant recurrences. Interpretation will be based on consensus assessment by nuclear medicine physicians and radiologists. Histopathology and/or conventional imaging (CT, FDG-PET, bone scintigraphy) will serve as the reference standards.
次要结局
- Correlation of standardized uptake values of 18F-FAPI to histologically proven characteristics of the breast cancer lesions(Baseline)
- Diagnostic accuracy of 18F-FAPI PET/MR compared to MR only in prediction/evaluation of response to neoadjuvant chemotherapy(From baseline to surgery (~3-6 months))
- Diagnostic accuracy of 18F-FAPI PET/MR compared to standard CT/bone scintigraphy in staging of breast cancer(Baseline)
- Diagnostic accuracy of 18F-FAPI PET/MR compared to CT/bone scintigraphy in detection of recurrence.(Baseline)
- Diagnostic accuracy of 18F-FAPI PET/MR compared to 18F-FDG PET/CT.(Baseline)