Accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic Cancer
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 Overview
Status
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Bin Qiu, M.D.
- Phone Number: 01082265968
- Email: 542122203@qq.com
Study Locations
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Beijing
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Beijing, Beijing, China
- Recruiting
- Peking University Third Hospital
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Contact:
- Bin Qiu, M.D.
- Phone Number: 01082265968
- Email: 542122203@qq.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Dosimetry (D90) between pre-plan and post-plan
Time Frame: From the starting to the ending of the seed implantation (generally within 1 week).
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Dose covering 90% of target volume between pre-plan and post-plan
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From the starting to the ending of the seed implantation (generally within 1 week).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Success rate of seed implantation
Time Frame: From the starting to the ending of the seed implantation (generally within 1 day).
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Success rate of seed implantation
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From the starting to the ending of the seed implantation (generally within 1 day).
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|
Adverse event
Time Frame: Acute adverse event is defined as 1 month after seed implantation and beyond 1 month for chronic adverse event.
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Such as pneumoperitoneum, subcutaneous emphysema, hemorrhage, infection, etc.
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Acute adverse event is defined as 1 month after seed implantation and beyond 1 month for chronic adverse event.
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Operating duration
Time Frame: From the starting to the ending of the seed implantation (generally within 2 hours)
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Operating duration from the starting to the ending
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From the starting to the ending of the seed implantation (generally within 2 hours)
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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
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Local progression-free survival:Duration of the seed implantation to local tumor progression
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Junjie Wang, M.D., Peking University Third Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChiECRCT20220009
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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