Breast CancerOFFLINE-PET-PRNCT07543107
Verification of Range Accuracy and Correlation With Clinical Toxicity Using Offline PET/CT for Hypofractionated Proton Radiotherapy in Breast Cancer
An observational study of Breast Cancer, run by Ruijin Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Offline PET/CT scanning
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 16 Apr 2026to 31 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Pregnant or lactating female.
- Severe non-neoplastic medical comorbidities precluding radiotherapy.
- Inability to cooperate or comply with offline PET/CT examination.
About this study
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
- Being tested
- Offline PET/CT scanning
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Offline PET/CT scanningOther
Offline PET/CT scan performed after proton therapy to verify range accuracy; no therapeutic intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Offline PET/CT scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Up to 24 months after completion of proton radiotherapy
Secondary outcomes (3)
Correlation between range error and lung dosimetric parameters
Analyze the correlation between proton range error and lung V5, V10, V20
Measured: During proton radiotherapy
Correlation between range error and rib dosimetric parameters
Analyze the correlation between proton range error and rib Dmax, V30
Measured: During proton radiotherapy
Performance of PET signal-proton range prediction model
Establish and evaluate the PET signal-proton range quantitative model using Monte Carlo simulation
Measured: During proton radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start16 Apr 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Cao, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543107
- Sponsor's protocol ID
- OFFLINE-PET-PR
- Acronym
- OFFLINE-PET-PR
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of Range Accuracy and Correlation With Clinical Toxicity Using Offline PET/CT for Hypofractionated Proton Radiotherapy in Breast Cancer
- ClinicalTrials.gov ID
- NCT07543107
- Acronym / sponsor ID
- OFFLINE-PET-PR / OFFLINE-PET-PR
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 16 Apr 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Proton Therapy Cohort | – | Other: Offline PET/CT scanningThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnant or lactating female.
- Severe non-neoplastic medical comorbidities precluding radiotherapy.
- Inability to cooperate or comply with offline PET/CT examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Offline PET/CT scanningOffline PET/CT scan performed after proton therapy to verify range accuracy; no therapeutic intervention | Other | Breast Cancer Proton Therapy Cohort |
Primary outcome
Proton beam range accuracy verified by offline PET/CT
Time frame: During proton radiotherapy (at the time of offline PET/CT scanning)
Quantify the range accuracy of hypofractionated proton radiotherapy for breast cancer using offline PET/CT imaging
Correlation between range error and radiation pneumonitis
Time frame: Up to 24 months after completion of proton radiotherapy
Evaluate the correlation between proton range error measured by offline PET/CT and the incidence of radiation pneumonitis
Correlation between range error and rib fracture
Time frame: Up to 24 months after completion of proton radiotherapy
Evaluate the correlation between proton range error measured by offline PET/CT and the incidence of rib fracture
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Ruijin Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proton beam range accuracy verified by offline PET/CT (time frame: During proton radiotherapy (at the time of offline PET/CT scanning)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.