Verification of Range Accuracy and Correlation With Clinical Toxicity Using Offline PET/CT for Hypofractionated Proton Radiotherapy in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Proton beam range accuracy verified by offline PET/CT
研究概览
简要总结
This is a single-arm, single-center, prospective observational study. It uses offline PET/CT to verify and quantify the range accuracy of hypofractionated proton radiotherapy for postoperative breast cancer. The correlation between range error and clinical toxicities (radiation pneumonitis, rib fracture) will be analyzed. A PET signal-proton range correlation model will be established using Monte Carlo simulation to provide evidence for optimizing proton therapy planning.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Written informed consent obtained.
- •Female aged ≥18 years.
- •Pathologically confirmed breast cancer after curative surgery (breast-conserving or mastectomy) and indicated for postoperative adjuvant radiotherapy.
- •Scheduled to receive moderate or ultra-hypofractionated proton therapy.
- •KPS ≥80, expected survival >5 years.
- •Well-healed surgical incision without infection.
- •Fertile females must use contraception for ≥1 month before screening and throughout the study.
排除标准
- •Pregnant or lactating female.
- •Severe non-neoplastic medical comorbidities precluding radiotherapy.
- •Inability to cooperate or comply with offline PET/CT examination.
研究组 & 干预措施
Breast Cancer Proton Therapy Cohort
This is a single prospective cohort of female patients with pathologically confirmed breast cancer after curative surgery, who are scheduled to receive moderate or ultra-hypofractionated proton radiotherapy. No additional therapeutic intervention is applied; only offline PET/CT scans are performed after proton treatment for range accuracy verification. Patients will be followed up for 24 months to assess radiation pneumonitis, rib fracture, and dosimetric parameters.
干预措施: Offline PET/CT scanning (Other)
结局指标
主要结局
Proton beam range accuracy verified by offline PET/CT
时间窗: During proton radiotherapy (at the time of offline PET/CT scanning)
Quantify the range accuracy of hypofractionated proton radiotherapy for breast cancer using offline PET/CT imaging
Correlation between range error and radiation pneumonitis
时间窗: Up to 24 months after completion of proton radiotherapy
Evaluate the correlation between proton range error measured by offline PET/CT and the incidence of radiation pneumonitis
Correlation between range error and rib fracture
时间窗: Up to 24 months after completion of proton radiotherapy
Evaluate the correlation between proton range error measured by offline PET/CT and the incidence of rib fracture
次要结局
- Correlation between range error and lung dosimetric parameters(During proton radiotherapy)
- Correlation between range error and rib dosimetric parameters(During proton radiotherapy)
- Performance of PET signal-proton range prediction model(During proton radiotherapy)