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Recruiting NCT05804916

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

Phase II / Phase III Interventional Breast Cancer Optical Surface Monitoring Technology Large-segment Radiotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surface Guided Radiation Therapy (SGRT).
Who it may be relevant to
Registry conditions: Breast Cancer, Optical Surface Monitoring Technology, Large-segment Radiotherapy. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Detailed description

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.

Interventions

  • Device Surface Guided Radiation Therapy (SGRT)
    SGRT and DIBH those two devices could be combined together to improve the accuracy in radiation therapy position and heart protection

Primary outcome measures

  • Accuracy of treatment location [Time frame: Change from baseline to the whole treatment procedure]
  • Incidence of patient coronary events/myocardial perfusion decline [Time frame: 3-year]
Secondary outcome measures (3)
  • Secondary efficacy indicators [Time frame: 3-year]
  • cardiac safety [Time frame: 5-year]
  • patients' quality of life [Time frame: 5-year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT05804916 · SGRT-BC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗