Spectral Precise Image Study for Brain Tumors

NCT07620470 | Recruiting FDA Device

• 1 other identifier: 301168
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to explore the image quality of spectral CT deep learning reconstruction technology (Spectral Precise Image) of patients with confirmed brain tumors. The main question it aims to answer is: The Image Quality (IQ) and diagnostic confidence of Spectral Precise Image reconstructions

Conditions

Brain Tumors

Outcome Measures

Primary Outcomes (2)

• Subjective Image quality using Likert score (1-5)

  Image quality will be assessed by 2 radiologists using Likert score on a scale ranging from 1(poor) to 5(Excellent)

  From date of image reconstruction until the date of image reading completion, anticipated 3Months.

• Objective Image Quality

  The objective quality of the image is evaluated by measuring the CT value shown in the image.

  From date of image reconstruction until the date of image reading completion, anticipated 3Months.

Interventions

This is an observational data collection study DEVICE

This is an observational data collection study

Eligibility Criteria

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

Study Population

The study population from Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

You may qualify if:

• Patients with clinical and radiology (MRI/CT) diagnosed brain tumors.
• Patients who underwent contrast enhanced scans using the Spectral CT 7500.
• Study participants with age ≥ 18 years old.
• Study participants that have signed Informed Consent Form (ICF)

You may not qualify if:

• The clinical data or radiological information is considered incomplete after evaluation by the investigator.
• Study participant that was enrolled in this study in the past
• Data from study participants deemed unsuitable for enrollment based on the investigator's evaluation

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jing Wang

  1277 Jiefang Avenue, Wuhan, Hubei Province, P. R. China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Wang

CONTACT

+8613986085216; xhwangjing@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: June 2, 2026
• Study Start: November 28, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 2, 2026

Record last verified: 2025-11

Locations

CN (1)