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Not yet recruiting NCT07543107

Verification of Range Accuracy and Correlation With Clinical Toxicity Using Offline PET/CT for Hypofractionated Proton Radiotherapy in Breast Cancer

Conditions: Breast Cancer

Sponsor: Ruijin Hospital

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
Offline PET/CT scanning
OTHER
Locations

Location information is not available.

Technical details
Status
Not yet recruiting
Study type
OBSERVATIONAL
Sex
Female only
Minimum age
18 Years
Healthy volunteers
No
Start date
16.04.2026
Completion date
31.08.2028
Registry ID
NCT07543107
Source
clinicaltrials.gov
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