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2023-10-08
2024-10-07
2025-10-07
57
NCT06342323
Peking University Third Hospital
Peking University Third Hospital
OBSERVATIONAL
The Optimal Number of Fiducial Marker for Stereotactic Body Radiotherapy
This is a clinical study focused on the use of fiducial marker-guided stereotactic body radiotherapy (SBRT) for treating malignant tumors, including lung, liver, pancreatic, and kidney/adrenal cancers. Here's a breakdown of the key components of the study: Study Design: Prospective, single-center, exploratory clinical study. Patient Enrollment: The study intends to enroll patients diagnosed with malignant tumors requiring fiducial marker-guided SBRT. Each tumor type (lung, liver, pancreatic, kidney/adrenal) aims to include 15 cases. Informed Consent: Patients are required to sign informed consent before participating in the study, indicating their understanding of the procedures, risks, and benefits involved. Intervention: Enrolled patients will undergo stereotactic radiotherapy for their respective malignant tumors. During this process, fiducial markers will be implanted according to the study protocol. Monitoring: Following implantation of fiducial markers, the study will monitor adverse events associated with the procedure. This includes any complications or side effects resulting from the marker implantation process. Success Rate: The study will assess the success rate of fiducial marker implantation. This likely involves evaluating the accuracy and reliability of marker placement for guiding SBRT treatment. SBRT Treatment Error: The study will also monitor SBRT treatment errors. This involves tracking any deviations or inaccuracies in the delivery of stereotactic radiotherapy, potentially caused by issues such as improper fiducial marker placement or technical errors in treatment administration. Overall, the study aims to explore the feasibility and effectiveness of using fiducial marker-guided SBRT for treating various types of malignant tumors to assess both the safety and the efficacy with a focus on patient outcomes and treatment accuracy.
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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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-03-19 | N/A | 2024-03-25 |
2024-03-25 | N/A | 2024-04-02 |
2024-04-02 | N/A | 2024-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
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Allocation:
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Interventional Model:
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Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Fiducial marker group all patient is observed for SBRT treatment error after fiducial marker implantation. | RADIATION: SBRT
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| success rate | the success rate of SBRT | 3 months after fiducial marker implantation during the SBRT |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Treatment error | Error in fiducial marker tracking during each fraction of SBRT | 3 months after fiducial marker implantation during the SBRT |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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Study Contact Name: Qiu Bin, M.D. Phone Number: +86010-82265968 Email: qiubin@pku.edu.cn |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
