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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06342323
Other study ID # IRB00006761-M2023235
Secondary ID ONFM-SBRT
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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