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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Offline PET/CT scanning | Other | Offline PET/CT scan performed after proton therapy to verify range accuracy; no therapeutic intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proton beam range accuracy verified by offline PET/CT | Quantify the range accuracy of hypofractionated proton radiotherapy for breast cancer using offline PET/CT imaging | During proton radiotherapy (at the time of offline PET/CT scanning) |
| Correlation between range error and radiation pneumonitis | Evaluate the correlation between proton range error measured by offline PET/CT and the incidence of radiation pneumonitis | Up to 24 months after completion of proton radiotherapy |
| Correlation between range error and rib fracture | Evaluate the correlation between proton range error measured by offline PET/CT and the incidence of rib fracture | Up to 24 months after completion of proton radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between range error and lung dosimetric parameters | Analyze the correlation between proton range error and lung V5, V10, V20 | During proton radiotherapy |
| Correlation between range error and rib dosimetric parameters |
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Inclusion Criteria:
Exclusion Criteria:
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Female patients aged 18 years or older with pathologically confirmed breast cancer after curative surgery, who are scheduled to receive moderate or ultra-hypofractionated proton radiotherapy at Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. Patients must have a KPS score ≥80, expected survival >5 years, and provide written informed consent.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Analyze the correlation between proton range error and rib Dmax, V30
| During proton radiotherapy |
| Performance of PET signal-proton range prediction model | Establish and evaluate the PET signal-proton range quantitative model using Monte Carlo simulation | During proton radiotherapy |
| D017437 |
| Skin and Connective Tissue Diseases |