Clinical application of uMI Panorama PET/CT with dual low-dose of PET and CT scan

To explore the optimal clinical imaging parameters of ultra-high time-of-flight resolution uMI Panorama PET/CT with AI technology and clinical significances of dual low-dose of PET and CT scan on oncology diagnosis

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2300078423

Enrollment

Unknown

Registered

2023-12-07

Start date

2024-01-01

Completion date

Unknown

Last updated

2023-12-10

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

Conditions

uMI Panorama PET/CT with dual low-dose of PET and CT scan

Interventions

Gold Standard:Pathology Comprehensive information such as enhanced CT, enhanced MRI, or clinical follow-up (= 6 months) results

Index test:1.Comparing the sensitivity of tumor diagnosis of uMI Panorama and conventional short axial PET/CT (uMI 550). 2.Compare the diagnostic performance of uMI Panorama and ultra long axial panor

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 18 to 80 years old, gender unlimited; 2. Patients with clinical suspicion or initial tumor by using PET/CT for diagnosis and staging, patients with tumor follow-up or suspected recurrence by using PET/CT for restaging, tumor patients after systematic therapy by using PET/CT for efficacy monitoring, and patients with unexplained increase in tumor markers by using PET/CT for tumor screening; 3. Able to provide clear pathological diagnosis results before or after examination; 4. Women of childbearing age who have no birth plan within three months; 5. Those who are conscious and able to take care of themselves; 6. Including 5-10% patients with BMI greater than 29 kg/m^2 of the total number of cases; 7. Those who agree to participate in this clinical trial and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who with poor compliance unable to cooperate with the examination; 2. Those who with mental disorders or mental retardation unable to cooperate with the examination; 3. Those who with fasting blood glucose = 11 mmol/L; 4. Pregnant women; 5. Patients with claustrophobia; 6. Image acquisition outside the range of 55 to 75 minutes after injection of 18F-FDG; 7. The interval between two PET scans was more than 30 minutes; 8. The researcher think somebody inappropriate to participate in this clinical trial.

Design outcomes

Primary

Measure	Time frame
Semi-quantitative analysis: Use the tumor tracking software included in the workstation to delineate;Qualitative analysis: Scoring the degree of developer uptake based on 5-PS scoring method;Disease detection rate;sensitivity;specificity;Positive predictive value;Negative predictive value;SUVmax;	—

Countries

China

Contacts

Public ContactShi Hongcheng

Zhongshan Hospital, Fudan University

shi.hongcheng@zs-hospital.sh.cn+86 136 8197 1579

Outcome results

None listed

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