Accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic CancerNCT05483452
Accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic Cancer
An observational study of Accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic Cancer, run by Peking University Third Hospital at 1 site in China.
Trial summary
In recent years, template guidance has been applied and developed in the field of puncture related operations, such as template-assisted radioactive seed implantation. With the guidance of template, needle pathway of seed implantation, biopsy and fiducial marker implantation can be precisely planned actual operation… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic Cancer
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 31 Mar 2025
- How long will I take part?
- 2 Years
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Abdominal and Pelvic cancer who are planned to undergo Coplanar Template Assisted Seed Implantation.
Who may be able to join
- Ages 18 to 85
- Single or multiple abdominal or pelvic tumors (solid, partially solid)
- Without taking drugs affecting coagulation and/or platelet aggregation are used; If used, the drug has been discontinued for a sufficient period of time (e.g. 1 week)
- KPS>60 points with expected survival >3 months, no serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture
- Planned seed implantation with applicable puncture path
- With informed consent.
Who cannot join
- Poor organ function (e.g. Liver decompensation)
- The lesion close to blood vessels and intestine, or there is portal vein hypertension and superior vena cava compression, etc., which are expected to have high risks of puncture bleeding and intestinal injury
- Poor compliance, unable to complete coordination
- Paticipant 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
Bin Qiu, M.D., 01082265968, 542122203@qq.com
About this study
In recent years, template guidance has been applied and developed in the field of puncture related operations, such as template-assisted radioactive seed implantation. With the guidance of template, needle pathway of seed implantation, biopsy and fiducial marker implantation can be precisely planned actual operation, which is conducive to the accurate proceeding. Templates can be divided into coplanar templates and non-coplanar templates. The digital coplanar template coordinate puncture system has been developed in China and has been applied in clinical practice.
In previous studies, coplanar template assisted CT-guided radioactive seed implantation has good clinical feasibility for head and neck cancer. However, the accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic cancer are lacking in prospective studies. The study aims to prospectively observe the accuracy and safety of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic cancer.
- Keywords
- Coplanar Template, Abdominal and Pelvic cancer, Seed Implantation
- Medical subject headings
- Pelvic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosimetry (D90) between pre-plan and post-plan
Dose covering 90% of target volume between pre-plan and post-plan
Measured: From the starting to the ending of the seed implantation (generally within 1 week).
Secondary outcomes (4)
Success rate of seed implantation
Success rate of seed implantation
Measured: From the starting to the ending of the seed implantation (generally within 1 day).
Adverse event
Such as pneumoperitoneum, subcutaneous emphysema, hemorrhage, infection, etc.
Measured: Acute adverse event is defined as 1 month after seed implantation and beyond 1 month for chronic adverse event.
Operating duration
Operating duration from the starting to the ending
Measured: From the starting to the ending of the seed implantation (generally within 2 hours)
Local progression-free survival
Local progression-free survival:Duration of the seed implantation to local tumor progression
Measured: From date of seed implantation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start1 Mar 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic 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
- 34 participants (estimated)
- Target duration
- 2 Years
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
- Investigators
- Junjie Wang, M.D., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483452
- Sponsor's protocol ID
- ChiECRCT20220009
- Status last verified
- Jun 2024
- First submitted
- 18 Jul 2022
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic Cancer
- ClinicalTrials.gov ID
- NCT05483452
- Acronym / sponsor ID
- ChiECRCT20220009
- Keywords
- Coplanar Template, Abdominal and Pelvic cancer, Seed Implantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 2 Aug 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.
In recent years, template guidance has been applied and developed in the field of puncture related operations, such as template-assisted radioactive seed implantation. With the guidance of template, needle pathway of seed implantation, biopsy and fiducial marker implantation can be precisely planned actual operation, which is conducive to the accurate proceeding. Templates can be divided into coplanar templates and non-coplanar templates. The digital coplanar template coordinate puncture system has been developed in China and has been applied in clinical practice.
In previous studies, coplanar template assisted CT-guided radioactive seed implantation has good clinical feasibility for head and neck cancer. However, the accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic cancer are lacking in prospective studies. The study aims to prospectively observe the accuracy and safety of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Abdominal and Pelvic cancer who are planned to undergo Coplanar Template Assisted Seed Implantation.
Key inclusion criteria (6 listed)
- Ages 18 to 85
- Single or multiple abdominal or pelvic tumors (solid, partially solid)
- Without taking drugs affecting coagulation and/or platelet aggregation are used; If used, the drug has been discontinued for a sufficient period of time (e.g. 1 week)
- KPS>60 points with expected survival >3 months, no serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture
- Planned seed implantation with applicable puncture path
Key exclusion criteria (4 listed)
- Poor organ function (e.g. Liver decompensation)
- The lesion close to blood vessels and intestine, or there is portal vein hypertension and superior vena cava compression, etc., which are expected to have high risks of puncture bleeding and intestinal injury
- Poor compliance, unable to complete coordination
- Paticipant 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.
Primary outcome
Dosimetry (D90) between pre-plan and post-plan
Time frame: From the starting to the ending of the seed implantation (generally within 1 week).
Dose covering 90% of target volume between pre-plan and post-plan
4 secondary outcomes
Success rate of seed implantation
Time frame: From the starting to the ending of the seed implantation (generally within 1 day).
Adverse event
Time frame: Acute adverse event is defined as 1 month after seed implantation and beyond 1 month for chronic adverse event.
Operating duration
Time frame: From the starting to the ending of the seed implantation (generally within 2 hours)
Local progression-free survival
Time frame: From date of seed implantation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
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.
Junjie Wang, M.D. principal investigator
Peking University Third Hospital
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 Accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic 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 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 18 Jun 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 Bin Qiu, M.D. (01082265968, 542122203@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosimetry (D90) between pre-plan and post-plan (time frame: From the starting to the ending of the seed implantation (generally within 1 week).). 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 18 Jun 2024.