Prospective Study of High-penetration Super-resolution Transcranial Ultrasound for Early Identification of Postoperative Intracranial Metallic Targets After Aneurysm Clipping

NCT07583225 | Not Yet Recruiting

• 1 other identifier: S2026-078-01
• Study Type: observational
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the patient-level early diagnostic performance of high-penetration super-resolution transcranial ultrasound for identifying intracranial metallic targets, and to further assess clip-level detection, localization, agreement, and its complementary value to routine postoperative imaging.This study does not alter routine clinical treatment. All participants will undergo standardized high-penetration super-resolution transcranial ultrasound within 3 hours after surgery. Postoperative CT is mandatory for all participants; CTA or other routine postoperative imaging will be obtained only when clinically indicated.

Conditions

Intracranial Aneurysms

Outcome Measures

Primary Outcomes (2)

• Patient-level sensitivity for identifying the presence or absence of intracranial metallic targets

  Within 24 hours after surgery upon completion of composite reference standard adjudication

• Patient-level specificity for identifying the presence or absence of intracranial metallic targets

  Within 24 hours after surgery upon completion of composite reference standard adjudication

Study Arms (2)

Positive group

Metallic-clip model group

Negative control group

Negative postoperative control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Positive group: standardized high-penetration super-resolution transcranial ultrasound within 3 hours after surgery, plus routine postoperative CT and CTA/other routine imaging when clinically indicated. Negative control group: standardized high-penetration super-resolution transcranial ultrasound within 3 hours after surgery, plus routine postoperative CT.

You may qualify if:

• Age 18-85 years;
• Positive group: patients undergoing intracranial aneurysm clipping with implanted metallic clips; negative control group: postoperative craniotomy patients without implanted clips;
• Ability to complete transcranial ultrasound within 3 hours after surgery;
• Availability of postoperative CT;
• Written informed consent from the participant or legally authorized representative.

You may not qualify if:

• Inability to complete standardized transcranial ultrasound;
• Missing postoperative CT;
• Inability to establish the composite reference standard;
• Presence of non-study-related metallic materials that may substantially interfere with target identification;
• Withdrawal of consent;
• Investigator judgment that continued participation is inappropriate.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Feng

  PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cao

CONTACT

+8601066937166; fc194@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05