Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342323
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-19
Brief Title:
The Optimal Number of Fiducial Marker for Stereotactic Body Radiotherapy
Sponsor:
Peking University Third Hospital
Organization:
Peking University Third Hospital
Study Overview
Official Title:
Study on the Optimal Number of Fiducial Marker Implanted With 3D-template Assitance for Stereotactic Body Radiotherapy
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ONFM-SBRT
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 kidneyadrenal cancers Heres 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 kidneyadrenal 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
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 kidneyadrenal 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ONFM-SBRT | OTHER | Peking university third hospital | None |