The Optimal Number of Fiducial Marker for Stereotactic Body Radiotherapy

Lung Cancer Clinical Trial

— ONFM-SBRT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06342323
• Other study ID #: IRB00006761-M2023235
• Secondary ID: ONFM-SBRT
• Status: Recruiting
• Start date: October 8, 2023
• Est. completion date: October 7, 2025

Study information

• Verified date: March 2024
• Source: Peking University Third Hospital
• Contact: Qiu Bin, M.D.
• Phone: +86010-82265968
• Email: qiubin[@]pku.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 57
• Est. completion date: October 7, 2025
• Est. primary completion date: October 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Radiation:
• SBRT
the fiducial marker was implanted with 3D template assistance under CT guidance

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Kothary N, Heit JJ, Louie JD, Kuo WT, Loo BW Jr, Koong A, Chang DT, Hovsepian D, Sze DY, Hofmann LV. Safety and efficacy of percutaneous fiducial marker implantation for image-guided radiation therapy. J Vasc Interv Radiol. 2009 Feb;20(2):235-9. doi: 10.1016/j.jvir.2008.09.026. Epub 2008 Nov 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success rate	the success rate of SBRT	3 months after fiducial marker implantation during the SBRT
Secondary	Treatment error	Error in fiducial marker tracking during each fraction of SBRT	3 months after fiducial marker implantation during the SBRT