Accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic Cancer

Recruiting

• Conditions: Accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic Cancer

• Registration Number: NCT05483452
• Lead Sponsor: Peking University Third Hospital

Brief 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, 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-18
• Study First Submitted QC: 2022-07-30
• Study First Posted: 2022-08-02
• Study Start: 2024-03-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-18
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1. Ages 18 to 85
2. Single or multiple abdominal or pelvic tumors (solid, partially solid)
3. 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)
4. KPS>60 points with expected survival >3 months, no serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture
5. Planned seed implantation with applicable puncture path
6. With informed consent.

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Exclusion Criteria

1. Poor organ function (e.g. Liver decompensation)
2. 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
3. Poor compliance, unable to complete coordination
4. Paticipant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dosimetry (D90) between pre-plan and post-plan	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

Secondary Outcome Measures

Name	Time	Method
Success rate of seed implantation	From the starting to the ending of the seed implantation (generally within 1 day).	Success rate of seed implantation
Local progression-free survival	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	Local progression-free survival:Duration of the seed implantation to local tumor progression
Operating duration	From the starting to the ending of the seed implantation (generally within 2 hours)	Operating duration from the starting to the ending
Adverse event	Acute adverse event is defined as 1 month after seed implantation and beyond 1 month for chronic adverse event.	Such as pneumoperitoneum, subcutaneous emphysema, hemorrhage, infection, etc.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China