Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Large-segment Radiotherapy | — | UNRESOLVED | — |
| Optical Surface Monitoring Technology | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surface Guided Radiation Therapy (SGRT) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SGRT+DIBH group
- description
- Patients with left breast cancer treated with SGRT combined with DIBH technique
- interventionNames
- Device: Surface Guided Radiation Therapy (SGRT)
- type
- NO_INTERVENTION
- label
- common+Free breath group
- description
- Patients with left breast cancer treated with traditional laser alignment with free breathing treatment
Primary outcomes (2)
- measure
- Accuracy of treatment location
- timeFrame
- Change from baseline to the whole treatment procedure
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available