Clinical trial · Observational

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

NCT07543107CI-TRIAL-00108903OFFLINE-PET-PRnot yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Offline PET/CT scanning	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

label
Breast Cancer Proton Therapy Cohort
description
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.
interventionNames
1. Other: Offline PET/CT scanning

Primary outcomes (3)

measure
Proton beam range accuracy verified by offline PET/CT
timeFrame
During proton radiotherapy (at the time of offline PET/CT scanning)
description
Quantify the range accuracy of hypofractionated proton radiotherapy for breast cancer using offline PET/CT imaging
measure
Correlation between range error and radiation pneumonitis
timeFrame

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.