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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

556 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2027-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Stereotactic Radiotherapy With Different Fractionation Modes for the Early Lung Cancer

NCT05802641

Lung Cancer Radiotherapy Stereotactic Body Radiotherapy +1 more

UNKNOWN

Single Ultra-high Dose Stereotactic Body Radiation Therapy for Early Lung Cancer

NCT05802654

Early Lung Cancer Stereotactic Body Radiotherapy

NOT_YET_RECRUITING NA

The Impact of Respiratory Training of DIBH Radiotherapy for Breast Cancer

NCT06488391

Breast Cancer

RECRUITING NA

Prospective Study of Particle Radiotherapy for Breast Cancer With Different Arm Position

NCT05878678

Breast Cancer

UNKNOWN PHASE2

Safety and Efficacy of SBRT in the Treatment of Thoracic Malignant Tumors at Different Sites

NCT05349552

Radiotherapy Thoracic Cancer Safety and Efficacy

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Optical Surface Monitoring Technology Large-segment Radiotherapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Control group: Patients with left breast cancer treated with traditional laser alignment with a free breathing treatment Study group: Patients with left breast cancer treated with SGRT combined with the DIBH technique

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open Label

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SGRT+DIBH group

Patients with left breast cancer treated with SGRT combined with DIBH technique

Group Type EXPERIMENTAL

Surface Guided Radiation Therapy (SGRT)

Intervention Type DEVICE

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

common+Free breath group

Patients with left breast cancer treated with traditional laser alignment with free breathing treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Deep Inspiration Breath Hold (DIBH) technique

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No