Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Location status: Recruiting
NCT Number: NCT05804916
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.
Interested in participating?
Request Info18 year–70 year
Female
Interventional
Phase 2 / Phase 3
Beijing, Beijing Municipality, 100730, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: 3-year
including the cardiac enzymes, ECG and myocardial perfusion
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
Time frame: 5-year
cardiac injury events include myocardial enzymes, electrocardiogram, echo, etc
Time frame: 5-year
scale scores of EORTC-QLQ-BR23, 0-100 scores, higher scores mean a better outcome.
Contact information is provided by the study sponsor or research team.
Fuquan ZHANG, PhD
CONTACT
Xiaorong HOU, PhD
CONTACT
Peking Union Medical College Hospital
Other
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
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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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