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The Optimal Number of Fiducial Marker for Stereotactic Body Radiotherapy

Study on the Optimal Number of Fiducial Marker Implanted With 3D-template Assitance for Stereotactic Body Radiotherapy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06342323
Acronym
ONFM-SBRT
Enrollment
57
Registered
2024-04-02
Start date
2023-10-08
Completion date
2025-10-07
Last updated
2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer, Lung Cancer, Pancreatic Cancer, Renal Cell Carcinoma

Keywords

fiducial marker, SBRT, lung caner, liver cancer, pancreatic cancer, renal cell carcinoma

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.

Interventions

RADIATIONSBRT

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

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
success rate3 months after fiducial marker implantation during the SBRTthe success rate of SBRT

Secondary

MeasureTime frameDescription
Treatment error3 months after fiducial marker implantation during the SBRTError in fiducial marker tracking during each fraction of SBRT

Countries

China

Contacts

Primary ContactQiu Bin, M.D.
qiubin@pku.edu.cn+86010-82265968

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026