Lung CancerONFM-SBRTNCT06342323
The Optimal Number of Fiducial Marker for Stereotactic Body Radiotherapy
An observational study of Lung Cancer and Liver Cancer, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Liver Cancer, Pancreatic Cancer
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2023to 7 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with lung cancer, liver cancer, renal cancer, pancreatic cancer who going to have fiducial marker guided SBRT was all eligible.
Who may be able to join
- Patient with lung cancer, liver cancer, renal cancer, pancreatic cancer.
- Going to have SBRT.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Qiu Bin
About this study
Official title: Study on the Optimal Number of Fiducial Marker Implanted With 3D-template Assitance for Stereotactic Body Radiotherapy
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.
Read more
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
- Being tested
- SBRT
- Keywords
- fiducial marker, SBRT, lung caner, liver cancer, pancreatic cancer, renal cell carcinoma
- Medical subject headings
- Lung Neoplasms, Liver Neoplasms, Pancreatic Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
the fiducial marker was implanted with 3D template assistance under CT guidance
| Study group | Role | What they receive |
|---|---|---|
| Fiducial marker group | all patient is observed for SBRT treatment error after fiducial marker implantation. Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate
the success rate of SBRT
Measured: 3 months after fiducial marker implantation during the SBRT
Secondary outcomes (1)
Treatment error
Error in fiducial marker tracking during each fraction of SBRT
Measured: 3 months after fiducial marker implantation during the SBRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start8 Oct 2023
- Primary completion7 Oct 2024 (estimated)
- Study completion7 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiu Bin, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342323
- Sponsor's protocol ID
- IRB00006761-M2023235
- Other IDs
- ONFM-SBRT
- Acronym
- ONFM-SBRT
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 19019700
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Optimal Number of Fiducial Marker Implanted With 3D-template Assitance for Stereotactic Body Radiotherapy
- ClinicalTrials.gov ID
- NCT06342323
- Acronym / sponsor ID
- ONFM-SBRT / IRB00006761-M2023235
- Conditions
- Lung Cancer, Liver Cancer, Pancreatic Cancer, Renal Cell Carcinoma
- Keywords
- fiducial marker, SBRT, lung caner, liver cancer, pancreatic cancer, renal cell carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 8 Oct 2023 (actual)
- Primary completion
- 7 Oct 2024 (estimated)
- Study completion
- 7 Oct 2025 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fiducial marker group | – | Radiation: SBRTall patient is observed for SBRT treatment error after fiducial marker implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with lung cancer, liver cancer, renal cancer, pancreatic cancer who going to have fiducial marker guided SBRT was all eligible.
Key inclusion criteria (2 listed)
- Patient with lung cancer, liver cancer, renal cancer, pancreatic cancer.
- Going to have SBRT.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRTthe fiducial marker was implanted with 3D template assistance under CT guidance | Radiation | Fiducial marker group |
Primary outcome
success rate
Time frame: 3 months after fiducial marker implantation during the SBRT
the success rate of SBRT
1 secondary outcome
Treatment error
Time frame: 3 months after fiducial marker implantation during the SBRT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Background: PubMed 19019700Kothary 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Liver Cancer, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiu Bin, M.D. (+86010-82265968, qiubin@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate (time frame: 3 months after fiducial marker implantation during the SBRT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06342323, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.