Not Yet RecruitingNot Applicable

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

30 participantsStarted 2026-04-16

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

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

What they're measuring

Proton beam range accuracy verified by offline PET/CT

Timeframe: During proton radiotherapy (at the time of offline PET/CT scanning)

Correlation between range error and radiation pneumonitis

Timeframe: Up to 24 months after completion of proton radiotherapy

Correlation between range error and rib fracture

Timeframe: Up to 24 months after completion of proton radiotherapy

Trial details

NCT IDNCT07543107

SponsorRuijin Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-08-31

View on ClinicalTrials.gov More Breast Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

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

What they're measuring

Proton beam range accuracy verified by offline PET/CT

Timeframe: During proton radiotherapy (at the time of offline PET/CT scanning)

Correlation between range error and radiation pneumonitis

Timeframe: Up to 24 months after completion of proton radiotherapy

Correlation between range error and rib fracture

Timeframe: Up to 24 months after completion of proton radiotherapy