Radioactive Iodine-125 BrachytherapyNCT05351268
3DPCT Combined With CT Guided RISI in the Treatment of Thoracic Malignant Tumors
A study testing Radioactive seed brachytherapy in people with Radioactive Iodine-125 Brachytherapy and Thoracic Cancer, run by Peking University Third Hospital at 1 site in China.
Trial summary
The main technical difficulties in radioactive iodine-125 seed implantation (RISI) lie in the complexity of operation and the control of operation quality. The current data shows that under the combined guidance of 3D-printing template and CT, the accuracy of RISI has been significantly improved, and the actual target… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radioactive Iodine-125 Brachytherapy, Thoracic Cancer, 3D Printing Coplanar Template
- What is being tested?
- Radioactive seed brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 30 Apr 2026
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathological diagnosis of malignant tumor of chest, lesion diameter less than 7 cm.
- There is no extensive systemic metastasis or although there is metastasis, the metastasis have been controlled by early treatment.
- No bleeding tendency, anticoagulant therapy and / or antiplatelet coagulation drugs should be stopped for at least 1 week before treatment.
- No serious or uncontrolled underlying diseases (such as severe or uncontrolled hypertension, diabetes, cardiovascular and cerebrovascular diseases and organ dysfunction) are found.
- There is a suitable puncture path, and the therapeutic dose is expected to be achieved.
- KPS > 70, expected to tolerate puncture / seed implantation, and expected survival time greater than 3 months.
Who cannot join
- Severe impairment of lung function (such as FEV1 < 40% predicted value, FVC < 50% predicted value, DLCO < 40% predicted value).
- High risk of skin invasion and ulceration at the puncture site before treatment.
- There is a large range of liquefaction and necrosis in the lesion, and the expected seed distribution would be poor.
- Pregnant women, lactating women and mentally ill patients.
- The patient with poor compliance and unable to complete the treatment.
- Other conditions of the researchers who think it is not suitable to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Junjie Wang, M.D., 008601082265921, junjiewang_edu@sina.cn
About this study
Official title: Safety and Efficacy of 3D Printing Coplanar Template Combined With CT Guided Radioactive I-125 Seed Implantation in the Treatment of Thoracic Malignant Tumors
The main technical difficulties in radioactive iodine-125 seed implantation (RISI) lie in the complexity of operation and the control of operation quality. The current data shows that under the combined guidance of 3D-printing template and CT, the accuracy of RISI has been significantly improved, and the actual target dose could meet the design requirements of preoperative plan.
At present, 3D printing templates (3DPT) are divided into non-coplanar templates (3DPNCT) and coplanar templates (3DPCT). In clinical practice, due to the complex technical requirements, high production cost and long printing time of 3DPNCT, a considerable number of patients can also complete the treatment with 3DPCT. Moreover, compared with 3DPNCT, 3DPCT has the advantages of accurate needle path control, fast needle path adjustment, convenient for intraoperative real-time optimization, without waiting for printing time, easy for doctors to master, lower cost than 3DPNCT, and easy to carry out at the grass-roots level. Therefore, this study intends to explore 3DPCT technology to further clarify: (1) the accuracy of 3DPCT assisted CT guided RISI in the treatment of thoracic malignant tumors; (2) the short-term efficacy and toxicity of 3DPCT assisted CT guided RISI in the treatment of thoracic malignant tumors.
- Conditions
- Radioactive Iodine-125 Brachytherapy, Thoracic Cancer, 3D Printing Coplanar Template, Nuclear Radiation Effects
- Being tested
- Radioactive seed brachytherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radioactive seed brachytherapyRadiation
The radioactive Iodine-125 seed can release low dose of irradiation persistently which kills tumors cell and causes less damage to normal tissue at the same time. The treatment was performed under CT monitoring. 3D-printing coplanar template includes information on the path of the implantation needle, the needle path can be controlled accurately which can make the operation more accurate.
| Study group | Role | What they receive |
|---|---|---|
| 3DPCT and CT guided RISI | Experimental | All patients were treated with clinical routine treatment: 3DPCT combined with CT guided radioactive seed implantation. Collect patient information and treatment information for analysis. Receives: Radiation: Radioactive seed brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local progression free survival
The time from the date of SBRT to the date of local recurrence or death or the date of last observation.
Measured: From the beginning of the treatment to 2 years after the treatment.
Incidence of adverse events
The adverse events are evaluated by the common terminology criteria for adverse events (CTCAE). The rate of each adverse event will be measured.
Measured: From the beginning of the treatment to 2 years after the treatment.
Secondary outcomes (1)
Overall survival
The time from the date of seeds implantation to the date of death from any cause or the date of last observation.
Measured: From the beginning of the treatment to 2 years after the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 May 2022
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radioactive Iodine-125 BrachytherapyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351268
- Sponsor's protocol ID
- BYSY-2022-3DPCT-TC
- Status last verified
- Dec 2023
- First submitted
- 20 Apr 2022
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of 3D Printing Coplanar Template Combined With CT Guided Radioactive I-125 Seed Implantation in the Treatment of Thoracic Malignant Tumors
- ClinicalTrials.gov ID
- NCT05351268
- Acronym / sponsor ID
- BYSY-2022-3DPCT-TC
- Conditions
- Radioactive Iodine-125 Brachytherapy, Thoracic Cancer, 3D Printing Coplanar Template, Nuclear Radiation Effects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 28 Apr 2022 (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.
The main technical difficulties in radioactive iodine-125 seed implantation (RISI) lie in the complexity of operation and the control of operation quality. The current data shows that under the combined guidance of 3D-printing template and CT, the accuracy of RISI has been significantly improved, and the actual target dose could meet the design requirements of preoperative plan.
At present, 3D printing templates (3DPT) are divided into non-coplanar templates (3DPNCT) and coplanar templates (3DPCT). In clinical practice, due to the complex technical requirements, high production cost and long printing time of 3DPNCT, a considerable number of patients can also complete the treatment with 3DPCT. Moreover, compared with 3DPNCT, 3DPCT has the advantages of accurate needle path control, fast needle path adjustment, convenient for intraoperative real-time optimization, without waiting for printing time, easy for doctors to master, lower cost than 3DPNCT, and easy to carry out at the grass-roots level. Therefore, this study intends to explore 3DPCT technology to further clarify: (1) the accuracy of 3DPCT assisted CT guided RISI in the treatment of thoracic malignant tumors; (2) the short-term efficacy and toxicity of 3DPCT assisted CT guided RISI in the treatment of thoracic malignant tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3DPCT and CT guided RISI | Experimental | Radiation: Radioactive seed brachytherapyAll patients were treated with clinical routine treatment: 3DPCT combined with CT guided radioactive seed implantation. Collect patient information and treatment information for analysis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathological diagnosis of malignant tumor of chest, lesion diameter less than 7 cm.
- There is no extensive systemic metastasis or although there is metastasis, the metastasis have been controlled by early treatment.
- No bleeding tendency, anticoagulant therapy and / or antiplatelet coagulation drugs should be stopped for at least 1 week before treatment.
- No serious or uncontrolled underlying diseases (such as severe or uncontrolled hypertension, diabetes, cardiovascular and cerebrovascular diseases and organ dysfunction) are found.
- There is a suitable puncture path, and the therapeutic dose is expected to be achieved.
Key exclusion criteria (6 listed)
- Severe impairment of lung function (such as FEV1 < 40% predicted value, FVC < 50% predicted value, DLCO < 40% predicted value).
- High risk of skin invasion and ulceration at the puncture site before treatment.
- There is a large range of liquefaction and necrosis in the lesion, and the expected seed distribution would be poor.
- Pregnant women, lactating women and mentally ill patients.
- The patient with poor compliance and unable to complete the treatment.
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 |
|---|---|---|
| Radioactive seed brachytherapyThe radioactive Iodine-125 seed can release low dose of irradiation persistently which kills tumors cell and causes less damage to normal tissue at the same time. The treatment was performed under CT monitoring. 3D-printing coplanar template includes information on the path of the implantation needle, the needle path can be controlled accurately which can make the operation more accurate. | Radiation | 3DPCT and CT guided RISI |
Primary outcome
Local progression free survival
Time frame: From the beginning of the treatment to 2 years after the treatment.
The time from the date of SBRT to the date of local recurrence or death or the date of last observation.
Incidence of adverse events
Time frame: From the beginning of the treatment to 2 years after the treatment.
The adverse events are evaluated by the common terminology criteria for adverse events (CTCAE). The rate of each adverse event will be measured.
1 secondary outcome
Overall survival
Time frame: From the beginning of the treatment to 2 years after the treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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PET/CT-Guided Biological Target Volume Delineation and Dose Optimization for Radioactive Seed Implantation Therapy in Malignant Tumors
Malignant Tumors
RecruitingPhase 2
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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?
A study testing Radioactive seed brachytherapy in people with Radioactive Iodine-125 Brachytherapy and Thoracic 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 6 inclusion and 6 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 20 Dec 2023. 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 Zhe Ji, M.D. (008618710002823, aschoff@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local progression free survival (time frame: From the beginning of the treatment to 2 years after the treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2023.