Spectral Precise Image Study for Brain Tumors
Clinical Study for Exploring Image Quality the Spectral Precise Image in Patients With Diagnosed Intracranial Tumors
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Jing Wang
- Phone Number: +8613986085216
- Email: xhwangjing@hust.edu.cn
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China
- Recruiting
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective Image quality using Likert score (1-5)
Time Frame: From date of image reconstruction until the date of image reading completion, anticipated 3Months.
|
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
Time Frame: From date of image reconstruction until the date of image reading completion, anticipated 3Months.
|
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.
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Jing Wang, 1277 Jiefang Avenue, Wuhan, Hubei Province, P. R. China
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 301168
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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