Clinical trial NCT05483452: Accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic Cancer
Official title: Accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Accuracy of Coplanar Template Assisted Seed Implantation for Abdominal and Pelvic Cancer
Keywords: Coplanar Template
Abdominal and Pelvic cancer
Seed Implantation
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Abdominal and Pelvic cancer who are planned to undergo Coplanar Template Assisted Seed Implantation.

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.


Eligibility 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.

Primary outcomes:
measure: Dosimetry (D90) between pre-plan and post-plan
timeFrame: From the starting to the ending of the seed implantation (generally within 1 week).
Secondary outcomes:
measure: Success rate of seed implantation
timeFrame: From the starting to the ending of the seed implantation (generally within 1 day).
measure: Adverse event
timeFrame: Acute adverse event is defined as 1 month after seed implantation and beyond 1 month for chronic adverse event.
measure: Operating duration
timeFrame: From the starting to the ending of the seed implantation (generally within 2 hours)
measure: Local progression-free survival
timeFrame: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Junjie Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: