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Comparison of the efficacy of 18F-FDG and 18F-FAPI PET/CT in detecting lymph node metastasis in penile cancer

Comparison of the efficacy of 18F-FDG and 18F-FAPI PET/CT in detecting lymph node metastasis in penile cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400085605
Enrollment
Unknown
Registered
2024-06-13
Start date
2024-06-20
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

penile cancer

Interventions

Gold Standard:Pathologic findings after lymph node dissection
Index test:18F-FDG and 18F-FAPI PET/CT imaging

Sponsors

The Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients with biopsy or surgical pathologically confirmed squamous cell carcinoma of the penis. (2) Age: 18 to 75 years old. (3) Those who should undergo lymph node dissection according to the guidelines or require prophylactic lymph node dissection. (4) Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Claustrophobic or otherwise unable to complete the examination. (2) Alcoholic and drug-addicted patients, and those with mental disorders who are unable to cooperate. (3) Simultaneous combination of other malignant tumors. (4) Poor general condition that prevents completion of PET CT examination or inability to tolerate the procedure. (5) Poor compliance with psychiatric abnormalities or mental retardation and inability to cooperate with examination and treatment. (6) Other conditions that the clinical trial staff considers inappropriate for participation in this trial. (7) Those who refuse to undergo lymph node dissection.

Design outcomes

Primary

MeasureTime frame
Sensitivity, SE;Specificity, SP;Accuracy;Positive predicative value, PPV, PV+;Negative predictive value, NPV,PV-;Maximum Standardized Uptake Value, SUVmax;Mean Standardized Uptake Value, SUVmean;

Secondary

MeasureTime frame
Positive likelihood ratio;Negative likelihood ratio;

Countries

China

Contacts

Public ContactMin Zhao

Department of Nuclear Medicine, The Third Xiangya Hospital of Central South University

mzhao1981@csu.edu.cn+86 136 8737 3641

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 31, 2026