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

March 27, 2023 updated by: Peking Union Medical College Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

556

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SGRT+DIBH group
Patients with left breast cancer treated with SGRT combined with DIBH technique
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
Other Names:
  • Deep Inspiration Breath Hold (DIBH) technique
No Intervention: common+Free breath group
Patients with left breast cancer treated with traditional laser alignment with free breathing treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of treatment location
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
Change from baseline to the whole treatment procedure
Incidence of patient coronary events/myocardial perfusion decline
Time Frame: 3-year
including the cardiac enzymes, ECG and myocardial perfusion
3-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary efficacy indicators
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
3-year
cardiac safety
Time Frame: 5-year
cardiac injury events include myocardial enzymes, electrocardiogram, echo, etc
5-year
patients' quality of life
Time Frame: 5-year
scale scores of EORTC-QLQ-BR23, 0-100 scores, higher scores mean a better outcome.
5-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Anticipated)

April 1, 2027

Study Completion (Anticipated)

April 1, 2027

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGRT-BC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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