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NCT Number: NCT05804916

Optical Surface Monitoring Technology-Guided Large-Segment Radiotherapy for Breast Cancer

This study is a single-center,blinded, efficacious, phase III randomized clinical trial initiated by investigators. The primary objective is to investigate the use of Surface Guided Radiation Therapy (SGRT) in combination with Deep Inspiration Breath Hold (DIBH) technique for left breast cancer treatment, compared to traditional laser alignment with free breathing treatment. This approach offers superior positioning accuracy and improved heart protection without any increase in radiation or adverse reactions.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Xiaorong HOU, PhD

CONTACT

[email protected]

+86-13811963013

About this study

This is an investigator-initiated blinded, efficacious, phase III randomized clinical trial study. The study hypothesis is that the use of Surface Guided Radiation Therapy (SGRT) in combination with the Deep Inspiration Breath Hold (DIBH) technique for left breast cancer treatment can improve positioning accuracy and heart protection without any increase in radiation or adverse reactions. The primary endpoint of this study is the accuracy of the treatment location and incidence of patient coronary events/myocardial perfusion decline.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who have undergone breast-conserving surgery or modified radical mastectomy for left breast cancer;
  • Planned whole-breast ± supraclavicular region, chest wall ± supraclavicular region radiotherapy;
  • Able to perform deep inspiration breath-hold technique with breath-holding time >35s and can repeat it continuously for more than 6 times;
  • Patients who have not received neoadjuvant chemotherapy or breast reconstruction surgery;
  • No active heart disease, myocardial infarction, congestive heart failure or other cardiac diseases at baseline;
  • Patients are fully voluntary and able to sign the informed consent form 30 days before enrollment.

Exclusion criteria

  • Bilateral breast cancer;
  • No pathological diagnosis;
  • Remote metastasis;
  • Receiving neoadjuvant chemotherapy or breast reconstruction;
  • Have received mediastinal radiotherapy in the past;
  • Previous history of abdominal or pelvic radiotherapy;
  • Previous or secondary primary malignant tumor;
  • Serious cardiac insufficiency; Myocardial infarction or uncorrected unstable arrhythmia or uncorrected unstable angina pectoris occurred in the last 3 months; Pericardial disease.

Treatment and study plan

Surface Guided Radiation Therapy (SGRT)

Device

SGRT and DIBH those two devices could be combined together to improve the accuracy in radiation therapy position and heart protection

Other names: Deep Inspiration Breath Hold (DIBH) technique

Primary outcomes

  1. Accuracy of treatment location

    Time frame: Change from baseline to the whole treatment procedure

    surface optical monitoring technology and simulation of surface contour registration error generated by surface optical surface error, as well as errors obtained by Cone beam CT registration. The translational errors in the left-right (x), up-down (y), front-back (z) directions, and rotational errors Rx, Ry, Rz will be measured

  2. Incidence of patient coronary events/myocardial perfusion decline

    Time frame: 3-year

    including the cardiac enzymes, ECG and myocardial perfusion

Secondary outcomes

  1. Secondary efficacy indicators

    Time frame: 3-year

    Correlation between surface optical monitoring technology and CBCT offset values Correlation between positioning errors and dose pass rates Patient position movement within fractions

  2. cardiac safety

    Time frame: 5-year

    cardiac injury events include myocardial enzymes, electrocardiogram, echo, etc

  3. patients' quality of life

    Time frame: 5-year

    scale scores of EORTC-QLQ-BR23, 0-100 scores, higher scores mean a better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Fuquan ZHANG, PhD

CONTACT

[email protected]

+86-13311360431

Xiaorong HOU, PhD

CONTACT

[email protected]

+86-13811963013

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

A Single-center, Blinded, Efficacious, Phase III Randomized Clinical Trial Initiated by Investigators to Investigate the Use of Surface Guided Radiation Therapy (SGRT) in Combination With Deep Inspiration Breath Hold (DIBH) Technique for Left Breast Cancer Treatment, Compared to Traditional Laser Alignment With Free Breathing Treatment

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 7, 2023
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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