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Multicenter Study on the Feasibility of 18F-FDG PET/CT Imaging at 40 Minutes Post-Injection

Multicenter Study on the Feasibility of 18F-FDG PET/CT Imaging at 40 Minutes Post-Injection

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129428
Enrollment
Unknown
Registered
2026-08-04
Start date
2026-08-10
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

Malignant tumors

Interventions

Index test:Early and standard 18F-FDG PET/CT imaging. Participants will receive 18F-FDG by group and undergo PET/CT at 40 minutes, followed by a second PET scan on the same scanner at 60 minutes, to c

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 to 80 years, with no restriction on sex; 2. Patients with clinically suspected or newly diagnosed tumors who are scheduled to undergo PET/CT for diagnosis and staging; tumor patients who are scheduled to undergo PET/CT for follow-up or suspected recurrence and restaging; or tumor patients who are scheduled to undergo PET/CT for response evaluation after systemic treatment; 3. Patients who can provide a definitive pathological diagnosis before or after PET/CT examination, with an interval of no more than 4 weeks between pathological diagnosis and PET/CT examination, and who have not received anti-tumor treatment during this interval; 4. Women of childbearing potential with no pregnancy plan within 3 months; 5. Patients with good compliance, clear consciousness, and the ability to move and take care of themselves; 6. A stratified enrollment strategy will be adopted, with approximately 5%-10% of the total enrolled participants being high-BMI patients (BMI >29 kg/m²); 7. Participants who agree to participate in this clinical study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Poor general condition and inability to cooperate with the examination; 2. Mental disorders or intellectual developmental delay resulting in poor compliance and inability to cooperate with the examination; 3. Fasting blood glucose >11 mmol/L; 4. Pregnant women; 5. Patients with claustrophobia; 6. Other conditions deemed by the investigators to be unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Lesion detection sensitivity;

Secondary

MeasureTime frame
Number and detection rate of malignant lesions;Five-point visual score for lesion 18F-FDG uptake;Lesion standardized uptake values (SUVmax, SUVpeak, and SUVmean);Background-tissue signal-to-noise ratio;Interobserver agreement;Lesion-to-background ratios;Background-tissue mean standardized uptake value and standard deviation (SUVmean and SD);

Countries

China

Contacts

Public ContactShi Hongcheng

Zhongshan Hospital, Fudan University

shi.hongcheng@zs-hospital.sh.cn+86 21 64041990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026