Breast Cancer Radiotherapy PlanningNCT06796257
Monaco-Serial Biological Function K-value Index Constraint for Cardiac Dose
An observational study of Breast Cancer Radiotherapy Planning, run by Jianjun Lai.
Trial summary
Breast cancer is the most common malignant tumor in women globally, with radiotherapy being a crucial adjunctive treatment . However, due to the proximity of the breast radiotherapy target to the heart, there is a dose-effect relationship between radiation dose and the risk of radiation-induced heart disease, leading… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer Radiotherapy Planning
- What is being tested?
- radiotherapy planning
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2025to 1 Mar 2025
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients who have successfully completed left-sided breast cancer DIBH-IMRT radiotherapy.
Who may be able to join
- The patients who have successfully completed left-sided breast cancer DIBH-IMRT radiotherapy.
Who cannot join
- The patients who have not completed left-sided breast cancer DIBH-IMRT radiotherapy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Retrospective Study on the Monaco-Serial Biological Function K-value Index Constraint for Cardiac Dose
Breast cancer is the most common malignant tumor in women globally, with radiotherapy being a crucial adjunctive treatment . However, due to the proximity of the breast radiotherapy target to the heart, there is a dose-effect relationship between radiation dose and the risk of radiation-induced heart disease, leading to a significantly increased risk of cardiac complications in patients undergoing left-sided breast cancer radiotherapy . Modern radiotherapy planning systems, utilizing inverse intensity-modulated radiotherapy (IMRT) dose optimization algorithms, effectively limit radiation exposure to organs at risk while ensuring target dose conformity, and have been widely adopted in clinical practice . To further reduce heart dose, the deep inspiration breath-hold (DIBH) technique has become an essential method in recent breast cancer radiotherapy. DIBH increases lung volume, thereby expanding the distance between the target and the heart, enhancing dose attenuation in the target area and minimizing radiation exposure to the heart. The combination of DIBH with IMRT dose optimization algorithms effectively minimizes radiation to the heart and its substructures, reducing the risk of radiation-induced heart disease.
The Monaco radiotherapy planning system is one of the most widely used systems, employing the Monte Carlo dose calculation algorithm, which offers high accuracy and provides dose optimization results that are closer to actual radiation-induced damage. The Serial function within the system is one of the key biological optimization tools, particularly effective in dose constraints for the heart and its substructures. In Monaco-Serial, when the Power Law Exponent value, or K value, is set to 1, it is more sensitive to average dose constraints, and is commonly used for average dose constraints to the heart and its substructures in left breast cancer free-breathing IMRT (FB-IMRT) radiotherapy . However, in deep inspiration breath-hold IMRT (DIBH-IMRT), due to significant changes in the spatial relationship between the heart and the target, previous parameter settings may no longer provide the optimal solution, and there is currently no relevant research or To maximize the dose constraints for the heart and its substructures and reduce the risk of radiation-induced damage, this study conducted a retrospective analysis of 51 patients who had previously undergone left-sided breast cancer DIBH-IMRT. Radiotherapy plans were designed with different Monaco-Serial K values, followed by dosimetric comparisons. Additionally, the correlation between dose-volume changes of organs at risk (OARs) after K value adjustments and anatomical changes post-DIBH was analyzed. The aim is to identify the optimal K value setting for the Monaco-Serial biological optimization function in left-sided breast cancer DIBH-IMRT, providing data support for the clinical application of the Monaco system in designing DIBH-IMRT radiotherapy plans for left breast cancer.
The study included 51 left-sided breast cancer patients who underwent breast-conserving surgery followed by whole-breast radiotherapy, with an average age of 43.3 years (range: 29-72 years). All patients had good compliance and completed the entire DIBH treatment process. The workflow which includes CT simulation and positioning under both FB and DIBH, Monaco radiotherapy plan design, radiotherapy plan evaluation, and the correlation analysis of anatomical changes and dose reduction rates after DIBH.
- Conditions
- Breast Cancer Radiotherapy Planning
- Being tested
- radiotherapy planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapy planningOther
In this study, CT localization images from 32 patients were retrospectively used for radiotherapy treatment planning. Three radiotherapy plans were designed based on different K-value intervals of the Monaco-Serial biological function constraint for the heart. The dose-volume parameters of the organs at risk were compared.
What is being measured
The primary outcome is the main question the study is designed to answer.
In the Monaco radiotherapy planning system, the dose-volume metrics for organs at risk and the metrics for changes in anatomical structures are extracted.
In the radiotherapy planning system, the radiation dose-volume data for the patient's heart and lungs is extracted, specifically including the mean dose and maximum dose to the heart, the maximum dose and mean dose to the LAD (left anterior descending artery), and the V5, V20, V30, and mean dose to the affected lung tissue (units: Gy). Additionally, anatomical indicators following DIBH (Deep Inspiration Breath Hold) are observed in the radiotherapy planning system, including the volume increase of the affected lung (units: cm³ or %), the distance between the heart and the breast (units: cm), and the volume ratio between the heart and the affected lung (units: % or ratio).
Measured: 2025.3.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start25 Jan 2025 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Radiotherapy PlanningStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianjun Lai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianjun Lai, Zhejiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796257
- Sponsor's protocol ID
- PDIBT002
- Status last verified
- Jan 2025
- First submitted
- 19 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- 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 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study on the Monaco-Serial Biological Function K-value Index Constraint for Cardiac Dose
- ClinicalTrials.gov ID
- NCT06796257
- Acronym / sponsor ID
- PDIBT002
- Conditions
- Breast Cancer Radiotherapy Planning
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Jianjun LaiUniversity, hospital or other
- Study start
- 25 Jan 2025 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 28 Jan 2025 (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.
Breast cancer is the most common malignant tumor in women globally, with radiotherapy being a crucial adjunctive treatment . However, due to the proximity of the breast radiotherapy target to the heart, there is a dose-effect relationship between radiation dose and the risk of radiation-induced heart disease, leading to a significantly increased risk of cardiac complications in patients undergoing left-sided breast cancer radiotherapy . Modern radiotherapy planning systems, utilizing inverse intensity-modulated radiotherapy (IMRT) dose optimization algorithms, effectively limit radiation exposure to organs at risk while ensuring target dose conformity, and have been widely adopted in clinical practice . To further reduce heart dose, the deep inspiration breath-hold (DIBH) technique has become an essential method in recent breast cancer radiotherapy. DIBH increases lung volume, thereby expanding the distance between the target and the heart, enhancing dose attenuation in the target area and minimizing radiation exposure to the heart. The combination of DIBH with IMRT dose optimization algorithms effectively minimizes radiation to the heart and its substructures, reducing the risk of radiation-induced heart disease.
The Monaco radiotherapy planning system is one of the most widely used systems, employing the Monte Carlo dose calculation algorithm, which offers high accuracy and provides dose optimization results that are closer to actual radiation-induced damage. The Serial function within the system is one of the key biological optimization tools, particularly effective in dose constraints for the heart and its substructures. In Monaco-Serial, when the Power Law Exponent value, or K value, is set to 1, it is more sensitive to average dose constraints, and is commonly used for average dose constraints to the heart and its substructures in left breast cancer free-breathing IMRT (FB-IMRT) radiotherapy . However, in deep inspiration breath-hold IMRT (DIBH-IMRT), due to significant changes in the spatial relationship between the heart and the target, previous parameter settings may no longer provide the optimal solution, and there is currently no relevant research or To maximize the dose constraints for the heart and its substructures and reduce the risk of radiation-induced damage, this study conducted a retrospective analysis of 51 patients who had previously undergone left-sided breast cancer DIBH-IMRT. Radiotherapy plans were designed with different Monaco-Serial K values, followed by dosimetric comparisons. Additionally, the correlation between dose-volume changes of organs at risk (OARs) after K value adjustments and anatomical changes post-DIBH was analyzed. The aim is to identify the optimal K value setting for the Monaco-Serial biological optimization function in left-sided breast cancer DIBH-IMRT, providing data support for the clinical application of the Monaco system in designing DIBH-IMRT radiotherapy plans for left breast cancer.
The study included 51 left-sided breast cancer patients who underwent breast-conserving surgery followed by whole-breast radiotherapy, with an average age of 43.3 years (range: 29-72 years). All patients had good compliance and completed the entire DIBH treatment process. The workflow which includes CT simulation and positioning under both FB and DIBH, Monaco radiotherapy plan design, radiotherapy plan evaluation, and the correlation analysis of anatomical changes and dose reduction rates after DIBH.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients who have successfully completed left-sided breast cancer DIBH-IMRT radiotherapy.
Key inclusion criteria (1 listed)
- The patients who have successfully completed left-sided breast cancer DIBH-IMRT radiotherapy.
Key exclusion criteria (1 listed)
- The patients who have not completed left-sided breast cancer DIBH-IMRT radiotherapy.
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 |
|---|---|---|
| radiotherapy planningIn this study, CT localization images from 32 patients were retrospectively used for radiotherapy treatment planning. Three radiotherapy plans were designed based on different K-value intervals of the Monaco-Serial biological function constraint for the heart. The dose-volume parameters of the organs at risk were compared. | Other | – |
Primary outcome
In the Monaco radiotherapy planning system, the dose-volume metrics for organs at risk and the metrics for changes in anatomical structures are extracted.
Time frame: 2025.3.1
In the radiotherapy planning system, the radiation dose-volume data for the patient's heart and lungs is extracted, specifically including the mean dose and maximum dose to the heart, the maximum dose and mean dose to the LAD (left anterior descending artery), and the V5, V20, V30, and mean dose to the affected lung tissue (units: Gy). Additionally, anatomical indicators following DIBH (Deep Inspiration Breath Hold) are observed in the radiotherapy planning system, including the volume increase of the affected lung (units: cm³ or %), the distance between the heart and the breast (units: cm), and the volume ratio between the heart and the affected lung (units: % or ratio).
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 28 Jan 2025.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Radiotherapy Planning, run by Jianjun Lai.
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 1 inclusion and 1 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 28 Jan 2025. 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?
Contact Jianjun Lai (+8615924193343, 385806945@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In the Monaco radiotherapy planning system, the dose-volume metrics for organs at risk and the metrics for changes in anatomical structures are extracted. (time frame: 2025.3.1). 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 28 Jan 2025; AzTrials last refreshed its copy on 29 Oct 2026.