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

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Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT07543107

Run by

Ruijin Hospital

People needed

30

Starts

2026-04-16

Expected to finish

2028-08-31

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Pregnant or lactating female.
• Severe non-neoplastic medical comorbidities precluding radiotherapy.
• Inability to cooperate or comply with offline PET/CT examination.

Full record on ClinicalTrials.gov

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