Accuracy of Coplanar Template Assisted Seed Implantation... | NCT05483452

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

NCT05483452

Sponsor

Peking University Third Hospital

Status

Unknown status

Last Update Posted

Jun 18, 2024Actual

Enrollment

34Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2024Actual

Primary Completion Date

Mar 31, 2025Estimated

Completion Date

Mar 31, 2025Estimated

First Submitted Date

Jul 18, 2022

First Submission Date that Met QC Criteria

Jul 30, 2022

First Posted Date

Aug 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2024

Last Update Posted Date

Jun 18, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

34Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dosimetry (D90) between pre-plan and post-plan	Dose covering 90% of target volume between pre-plan and post-plan	From the starting to the ending of the seed implantation (generally within 1 week).

Secondary Outcomes

Measure	Description	Time Frame
Success rate of seed implantation	Success rate of seed implantation	From the starting to the ending of the seed implantation (generally within 1 day).
Adverse event	Such as pneumoperitoneum, subcutaneous emphysema, hemorrhage, infection, etc.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bin Qiu, M.D.	Contact	01082265968		542122203@qq.com

Overall Officials

Name	Affiliation	Role
Junjie Wang, M.D.	Peking University Third Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Third Hospital	Recruiting	Beijing	Beijing Municipality		China

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms