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AzTrials

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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

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.

  1. 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.

  1. First posted28 Jan 2025
  2. Study start25 Jan 2025 (estimated)
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion1 Mar 2025 (estimated)

Resources

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)
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

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.

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