Clinical trial NCT06342323: The Optimal Number of Fiducial Marker for Stereotactic Body Radiotherapy
Official title: Study on the Optimal Number of Fiducial Marker Implanted With 3D-template Assitance for Stereotactic Body Radiotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Liver Cancer
Pancreatic Cancer
Renal Cell Carcinoma
Keywords: fiducial marker
SBRT
lung caner
liver cancer
pancreatic cancer
renal cell carcinoma
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with lung cancer, liver cancer, renal cancer, pancreatic cancer who going to have fiducial marker guided SBRT was all eligible.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: success rate
timeFrame: 3 months after fiducial marker implantation during the SBRT
Secondary outcomes:
measure: Treatment error
timeFrame: 3 months after fiducial marker implantation during the SBRT
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References:
citation: 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.