Use of Imaging Markers by Fluorocholine PET/MR to Predict Molecular Subtypes and Clinical Outcomes of Breast Cancer: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Association Between Pre-treatment FCH PET/MR Parameters and Molecular Subtypes of Breast Cancer
研究概览
简要总结
Objectives:
Our study is conducted to use the pre-treatment Fluorocholine (FCH) Positron emission tomography/magnetic resonance (PET/MR) imaging in breast cancer patients, to investigate whether the conventional PET/MR imaging markers (maximum standardized uptake value [SUVmax], MR spectroscopy-derived choline analysis, dynamic contrast-enhanced MRI, apparent diffusion coefficient [ADC] analysis), and FCH PET/MR radiomic features, deep learning (DL) analysis are associated with molecular subtypes, clinical outcomes, treatment response, survival, and which parameters are more accurate for predictive purposes.
Primary study purposes:
-To investigate whether the pre-treatment FCH PET/MR imaging parameters are associated with molecular subtypes of breast cancers, and to evaluate the diagnostic performance for predictive purposes.
Secondary study purposes:
-To investigate whether the pre-treatment FCH PET/MR imaging parameters are associated with the factors related to clinical outcomes (histologic grade, prognosis) and to analyze which parameters are more accurate for predictive purposes.
Test drug:
Name: 18F- Fluorocholine (18F-FCH) Dosage form: N-([18F]fluoromethyl)-2-hydroxy-N,N-dimethylethan-1-aminium Strength: 3-5 MBq/kg per patient (5-6 mCi/mL at time of injection (TOI)) Dosage and administration: Intravenous injection.fluoromethyl
Selection criteria:
- Women aged 25-75 years old.
- Women diagnosed with breast cancer by pathological diagnosis from a core biopsy within 3 months and who will receive neoadjuvant chemotherapy (NAC) before surgery; or women with pathologically proven breast cancer within 3 months and who will receive operation (without pre-operative neoadjuvant chemotherapy).
- Women whose Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and life expectancy at least 3 months.
详细描述
Study steps / procedures:
- The study participants will receive pre-treatment whole-body PET/MR and breast PET/MR examinations.
- The whole-body PET/MR:
(1). The participant will undergo NPO for at least 6 hours before the examination.
(2). After intravenous injection of 5-6 mCi 18F- Fluorodeoxyglucose (FDG), the participant will rest for approximately 60 minutes, followed by a 20-25-minute whole-body PET/MR examination. FDG is a commercially available PET tracer approved for clinical diagnosis.
3. PET/MR of the breast:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 25-75 years old.
- •Women diagnosed with breast cancer by pathological diagnosis from a core biopsy within 3 months and who will receive neoadjuvant chemotherapy (NAC) before surgery; or women with pathologically proven breast cancer within 3 months and who will receive operation (without pre-operative neoadjuvant chemotherapy).
- •Women whose ECOG performance status between 0-2 and life expectancy at least 3 months.
排除标准
- •Women who are unable to cooperate with the examinations
- •Women who are pregnant, lactating or are planning to be pregnant
- •Women with estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2 or acute renal failure within 3 months, past history of renal dialysis.
- •Past history of claustrophobia
- •Past history of anaphylactoid reactions to MRI contrast agents or PET tracer agents.
- •Women with cardiac pacemaker, aneurysmal clip, mechanical valve replacement, recently applied coronary artery stent (within 3 months).
- •Past history of breast cancer or other malignancy within 5 years.
- •Women who underwent chemotherapy within a year.
- •Women who are not suitable to join the study according to the assessment by investigators.
结局指标
主要结局
Association Between Pre-treatment FCH PET/MR Parameters and Molecular Subtypes of Breast Cancer
时间窗: From enrollment to the end of study (follow up) at least 40 weeks.
To evaluate the association between pre-treatment FCH PET/MR imaging parameters and molecular subtypes of breast cancer, as well as their predictive diagnostic performance.
次要结局
- To investigate whether the pre-treatment FCH PET/MR imaging parameters are associated with the factors related to clinical outcomes (histologic grade, prognosis) and to analyze which parameters are more accurate for predictive purposes.(From enrollment, at least about 40 weeks (until the completion of chemotherapy, or when the surgical pathology comes out).)