Breast Cancer
Conditions
Brief summary
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.
Interventions
OTHEROffline PET/CT scanning
Offline PET/CT scan performed after proton therapy to verify range accuracy; no therapeutic intervention
Sponsors
Ruijin Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent obtained. 2. Female aged ≥18 years. 3. Pathologically confirmed breast cancer after curative surgery (breast-conserving or mastectomy) and indicated for postoperative adjuvant radiotherapy. 4. Scheduled to receive moderate or ultra-hypofractionated proton therapy. 5. KPS ≥80, expected survival \>5 years. 6. Well-healed surgical incision without infection. 7. Fertile females must use contraception for ≥1 month before screening and throughout the study.
Exclusion criteria
1. Pregnant or lactating female. 2. Severe non-neoplastic medical comorbidities precluding radiotherapy. 3. Inability to cooperate or comply with offline PET/CT examination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proton beam range accuracy verified by offline PET/CT | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between range error and lung dosimetric parameters | During proton radiotherapy | Analyze the correlation between proton range error and lung V5, V10, V20 |
| Correlation between range error and rib dosimetric parameters | During proton radiotherapy | Analyze the correlation between proton range error and rib Dmax, V30 |
| Performance of PET signal-proton range prediction model | During proton radiotherapy | Establish and evaluate the PET signal-proton range quantitative model using Monte Carlo simulation |
Outcome results
None listed