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

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Summary

NIH registered clinical trial NCT07543107, a single-arm prospective observational study evaluating offline PET/CT verification of proton range accuracy in hypofractionated radiotherapy for postoperative breast cancer. The study will analyze correlation between range error and clinical toxicities including radiation pneumonitis and rib fracture.

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What changed

A newly registered clinical trial NCT07543107 has been posted on ClinicalTrials.gov. The study is a single-arm, single-center prospective observational trial using offline PET/CT to verify and quantify range accuracy of hypofractionated proton radiotherapy for postoperative breast cancer. The trial will analyze correlation between range error and clinical toxicities (radiation pneumonitis, rib fracture) and establish a PET signal-proton range correlation model using Monte Carlo simulation.

Breast cancer patients being considered for proton therapy at the participating center may be eligible for enrollment. Clinical researchers and radiotherapy treatment planners may follow the study's findings regarding range verification and toxicity correlation to inform proton therapy optimization strategies.

Archived snapshot

Apr 22, 2026

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

Observational NCT07543107 Kind: OBSERVATIONAL Apr 21, 2026

Abstract

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

Interventions: Offline PET/CT scanning

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Last updated

Classification

Agency
NIH
Published
April 21st, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Clinical investigators
Industry sector
3345 Medical Device Manufacturing
Activity scope
Clinical trial registration Medical imaging research Radiotherapy planning
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Medical Devices Pharmaceuticals

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