Verification of Range Accuracy and Correlation With Clinical Toxicity Using Offline PET/CT for Hypofractionated Proton Radiotherapy in Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Offline PET/CT scanning.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Interventions
- Other Offline PET/CT scanning
Offline PET/CT scan performed after proton therapy to verify range accuracy; no therapeutic intervention
Primary outcome measures
- Proton beam range accuracy verified by offline PET/CT [Time frame: During proton radiotherapy (at the time of offline PET/CT scanning)]
- Correlation between range error and radiation pneumonitis [Time frame: Up to 24 months after completion of proton radiotherapy]
- Correlation between range error and rib fracture [Time frame: Up to 24 months after completion of proton radiotherapy]
Secondary outcome measures (3)
- Correlation between range error and lung dosimetric parameters [Time frame: During proton radiotherapy]
- Correlation between range error and rib dosimetric parameters [Time frame: During proton radiotherapy]
- Performance of PET signal-proton range prediction model [Time frame: During proton radiotherapy]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07543107 · OFFLINE-PET-PR