The Optimal Number of Fiducial Marker for Stereotactic Body Radiotherapy

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

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Recruitment Status

RECRUITING

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-08

Study Completion Date

2025-10-07

Brief Summary

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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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Detailed Description

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Conditions

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Lung Cancer Liver Cancer Pancreatic Cancer Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fiducial marker group

all patient is observed for SBRT treatment error after fiducial marker implantation.

SBRT

Intervention Type RADIATION

the fiducial marker was implanted with 3D template assistance under CT guidance

Interventions

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SBRT

the fiducial marker was implanted with 3D template assistance under CT guidance

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No