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

NCT07543107 | Not Yet Recruiting

• 1 other identifier: OFFLINE-PET-PR
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• Correlation between range error and lung dosimetric parameters

  During proton radiotherapy

• Correlation between range error and rib dosimetric parameters

  During proton radiotherapy

• Performance of PET signal-proton range prediction model

  During proton radiotherapy

Study Arms (1)

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.

Other: Offline PET/CT scanning

Interventions

Offline PET/CT scanning OTHER

Offline PET/CT scan performed after proton therapy to verify range accuracy; no therapeutic intervention

Breast Cancer Proton Therapy Cohort

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

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.

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 21, 2026
• Study Start: April 16, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share