RecruitingPhase 2Phase 3NCT05804916

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

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


Sponsor

Peking Union Medical College Hospital

Enrollment

556 participants

Start Date

Apr 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an optical surface monitoring system — a camera-based technology — to help guide and verify deep-breath-hold radiation therapy (DIBH) for left-sided breast cancer, with the goal of protecting the heart from radiation exposure. **You may be eligible if:** - You have had surgery for left-sided breast cancer (breast-conserving surgery or mastectomy) - You are planned to receive radiation therapy to the whole breast or chest wall - You can hold your breath for more than 35 seconds and repeat it at least 6 times in a row - You have not received neoadjuvant chemotherapy or had breast reconstruction - You have no active heart disease **You may NOT be eligible if:** - You have bilateral (both-sided) breast cancer - Cancer has spread to distant parts of the body - You have had chest, abdominal, or pelvic radiation in the past - You have a prior or second primary cancer - You have serious heart problems (heart failure, recent heart attack, unstable arrhythmia) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESurface 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


Locations(1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

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NCT05804916


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