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Clinical Study for Exploring Image Quality the Spectral Precise Image in Patients with Diagnosed Intracranial Tumors

Clinical Study for Exploring Image Quality the Spectral Precise Image in Patients with Diagnosed Intracranial Tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500111248
Enrollment
Unknown
Registered
2025-10-28
Start date
2025-10-31
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain tumors (gliomas, meningioma, pituitary tumor, brain metastases)

Interventions

Gold Standard:Patients with clinical and radiology diagnosed brain tumors.
Index test:The Image Quality (IQ) and diagnostic confidence of Spectral Precise Image reconstructions is at least as good as (non-inferior to)-iDose4 for conventional images and spectral images of Mon

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients with clinical and radiology (MRI/CT) diagnosed brain tumors; 2.Patients who underwent contrast enhanced scans using the Spectral CT 7500; 3.Study participants with age >= 18 years old; 4.Study participants that have signed Informed Consent Form (ICF).

Exclusion criteria

Exclusion criteria: 1.The clinical data or radiological information is considered incomplete after evaluation by the investigator; 2.Study participant that was enrolled in this study in the past; 3.Data from study participants deemed unsuitable for enrollment based on the investigator’s evaluation.

Design outcomes

Primary

MeasureTime frame
The Image Quality (IQ) and diagnostic confidence of Spectral Precise Image reconstructions is at least as good as (non-inferior to)-iDose4 for spectral images of MonoE (MonoE 40keV and MonoE 50keV);The Image Quality (IQ) and diagnostic confidence of Spectral Precise Image reconstructions is at least as good as (non-inferior to)-iDose4 for conventional images.;

Secondary

MeasureTime frame
To evaluate the lesion detection rate of SPI compared to the iDose4 reconstruction method.;To evaluate the objective quality (Noise, SNR, CNR) of the image reconstructed with SPI in comparison with iDose4;

Countries

China

Contacts

Public ContactWang Jing

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

jjwinflower@126.com+86 27 85726114

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026