Accuracy and Safety of Coplanar Template Assistance for Head and Neck Biopsies.

NCT05396183 | Unknown

• 1 other identifier: ChiECRCT20220052
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective single-arm cohort study to evaluate the accuracy and safety of three-dimensional printing co-planer template(3D-PCT) for computed tomography (CT)-guided neck and head biopsy .

Conditions

Head and Neck Neoplasms

Keywords

Head and Neck Neoplasms; biopsy; 3D-PCT

Outcome Measures

Primary Outcomes (1)

• Accuracy

  Depth and Angle difference between actual puncture and planned puncture pathway.

  During the operation.

Secondary Outcomes (2)

• Complication rate

  During the first month after operation.

• Pathological Diagnosis

  During the first month after operation.

Other Outcomes (2)

• Procedural duration

  During the operation.

• Radiation exposure

  During the operation.

Study Arms (1)

3D-PCT group

Participant will receive three-dimensional printing co-planar template (3D-PCT) assisted CT-guided head and neck neoplasm biopsy and prospective accuracy and safety data will record.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive eligible patient with head and neck masses or nodules, who are planned undergo biopsy with applicable puncture path in Peking university Third hospital will be enrolled.

You may qualify if:

• (1) Ages 18 to 80; (2) KPS\>70 points, an estimated life expectancy of greater than 3 months; (3)Head and neck masses or nodules can be revealed by CT scan, MRI or ultrasonic examination; (4) 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) ; (5) No serious or uncontrolled underlying diseases, clinical evaluation patients can tolerate puncture; (6) Planned biopsy with applicable puncture path; (7) With informed consent.

You may not qualify if:

• (1)Biopsy needle insertion route impeded by skeletal structures and close to blood vessels which have high risks of puncture bleeding; (2)Poor organ function (e.g. poorly controlled high blood pressure); (3) Any contraindication of percutaneous head and neck biopsy; (4) Poor compliance, unable to complete coordination; (5) Participant who is considered inappropriate or unwilling to participate in this clinical trial for other reasons.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Department of Radiation Oncology of Peking university third hospital

Beijing, Beijing Municipality, 10010, China

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Wang Junjie

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bin Qiu, MD

CONTACT

010-82265968; 15269757106@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Peking University

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: May 31, 2022
• Study Start: May 25, 2022
• Primary Completion: February 25, 2024
• Study Completion: March 25, 2024
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

CN (1)