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Multicenter Study on the Feasibility of 18F-FDG Total-body PET/CT Imaging at 6 Hours

Multicenter Study on the Feasibility of 18F-FDG Total-body PET/CT Imaging at 6 Hours

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129574
Enrollment
Unknown
Registered
2026-08-06
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:18F-FDG Total-body PET/CT delayed imaging.All participants will receive a single injection of 18F-FDG (3.7 MBq/kg) and undergo Total-body PET/CT imaging at 60 minutes and 6 hours after inje

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

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