The Optimal Number of Fiducial Marker for Stereotactic Body Radiotherapy

Recruiting

• Conditions: Liver Cancer; Pancreatic Cancer; Renal Cell Carcinoma; Lung Cancer
• Interventions: Radiation: SBRT

• Registration Number: NCT06342323
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-08
• Status Verified: 2024-03
• Study First Submitted: 2024-03-19
• Study First Submitted QC: 2024-03-25
• Last Update Submitted: 2024-03-25
• Study First Posted: 2024-04-02
• Last Update Posted: 2024-04-02
• Primary Completion: 2024-10-07
• Study Completion: 2025-10-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Patient with lung cancer, liver cancer, renal cancer, pancreatic cancer.
• Going to have SBRT.

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Exclusion Criteria

• Needle insertion route impeded by skeletal structures and close to blood vessels which have high risks of puncture bleeding;
• Poor organ function (e.g. poorly controlled high blood pressure);
• Poor compliance, unable to complete coordination;
• Participant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fiducial marker group	SBRT	all patient is observed for SBRT treatment error after fiducial marker implantation.

Primary Outcome Measures

Name	Time	Method
success rate	3 months after fiducial marker implantation during the SBRT	the success rate of SBRT

Secondary Outcome Measures

Name	Time	Method
Treatment error	3 months after fiducial marker implantation during the SBRT	Error in fiducial marker tracking during each fraction of SBRT

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China