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Trial Title:
Accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic Cancer
NCT ID:
NCT05483452
Condition:
Accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic Cancer
Conditions: Official terms:
Pelvic Neoplasms
Conditions: Keywords:
Coplanar Template
Abdominal and Pelvic cancer
Seed Implantation
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Patients with Abdominal and Pelvic cancer who are planned to undergo Coplanar Template
Assisted Seed Implantation.
Sampling method:
Non-Probability Sample
Criteria:
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:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Bin Qiu, M.D.
Phone:
01082265968
Email:
542122203@qq.com
Start date:
March 1, 2024
Completion date:
March 31, 2025
Lead sponsor:
Agency:
Peking University Third Hospital
Agency class:
Other
Source:
Peking University Third Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05483452
