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RecruitingNCT05483452Updated Jun 18, 2024

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

An observational study in Accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic Cancer, sponsored by Peking University Third Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-06-18.

Sponsored by Peking University Third Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
34
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

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

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Keywords

  • Coplanar Template
  • Abdominal and Pelvic cancer
  • Seed Implantation
03

In context

Pelvic Neoplasms

98 studies on the registry are indexed under Pelvic Neoplasms; 27 are open to participants now.

This study's planned enrollment of 34 is below the median of 184 across 34 observational studies indexed under Pelvic Neoplasms.

Browse Pelvic Neoplasms studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with Abdominal and Pelvic cancer who are planned to undergo Coplanar Template Assisted Seed Implantation.

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.

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
34 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Dosimetry (D90) between pre-plan and post-plan

    Dose covering 90% of target volume between pre-plan and post-plan

    Time frame: From the starting to the ending of the seed implantation (generally within 1 week).

Secondary outcomes

  1. Success rate of seed implantation

    Success rate of seed implantation

    Time frame: From the starting to the ending of the seed implantation (generally within 1 day).

  2. Adverse event

    Such as pneumoperitoneum, subcutaneous emphysema, hemorrhage, infection, etc.

    Time frame: Acute adverse event is defined as 1 month after seed implantation and beyond 1 month for chronic adverse event.

  3. Operating duration

    Operating duration from the starting to the ending

    Time frame: From the starting to the ending of the seed implantation (generally within 2 hours)

  4. Local progression-free survival

    Local progression-free survival:Duration of the seed implantation to local tumor progression

    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

07

Study locations

1 of 1 sites recruiting
  • Peking University Third Hospital
    Beijing, Beijing, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05483452
Lead sponsor
Peking University Third Hospital
Responsible party
Qiu Bin (Principal Investigator, Peking University Third Hospital) — Principal investigator
First posted
Aug 2, 2022
Start date
Mar 1, 2024
Primary completion
Mar 31, 2025 (estimated)
Completion
Mar 31, 2025 (estimated)
Last update
Jun 18, 2024

Study contacts

Bin Qiu, M.D.
Contact
542122203@qq.com
01082265968
Junjie Wang, M.D.
principal investigator · Peking University Third Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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