The Optimal Number of Fiducial Marker for Stereotactic Body Radiotherapy

NCT06342323 | Recruiting DMC

• 2 other identifiers: IRB00006761-M2023235ONFM-SBRT
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Liver Cancer; Pancreatic Cancer; Renal Cell Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• success rate

  the success rate of SBRT

  3 months after fiducial marker implantation during the SBRT

Secondary Outcomes (1)

• Treatment error

  3 months after fiducial marker implantation during the SBRT

Study Arms (1)

Fiducial marker group

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

Radiation: SBRT

Interventions

SBRT RADIATION

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

Fiducial marker group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related 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.

  PMID: 19019700 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Liver Neoplasms; Pancreatic Neoplasms; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Qiu Bin, M.D.

CONTACT

+86010-82265968; qiubin@pku.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor-in-charge

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 2, 2024
• Study Start: October 8, 2023
• Primary Completion: October 7, 2024
• Study Completion: October 7, 2025
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)