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Efficacy of 18F-FAPI PET/CT in Diagnosing UTUC: A Prospective, Single-Center Observational Study

Efficacy of 18F-FAPI PET/CT in Diagnosing UTUC: A Prospective, Single-Center Observational Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121395
Enrollment
Unknown
Registered
2026-03-30
Start date
2026-03-30
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Upper Tract Urothelial Carcinoma

Interventions

Gold Standard:Surgical histopathology

Sponsors

The Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Patients clinically diagnosed with malignant tumor of the renal pelvis or ureter (UTUC) by means such as ultrasound, CT urography (CTU), magnetic resonance imaging (MRI), ureteroscopy with or without biopsy pathology, or cytology/urine methylation testing; (2) Age: 18–85 years; (3) Assessed as high-risk UTUC according to guidelines, meeting at least one of the following criteria: a. Presence of hydronephrosis; b. Tumor diameter >= 2 cm; c. Cytology indicating high-grade tumor; d. Ureterorenoscopic biopsy indicating high-grade tumor; e. Multifocal tumor; f. Prior radical cystectomy for high-grade bladder cancer; g. Presence of multiple histological subtypes; h. CT findings suggestive of invasive tumor growth (cT2–cT4). Or imaging findings do not exclude regional lymph node metastasis (cN+); (4) Voluntarily agree to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Explicitly refuse to undergo radical nephroureterectomy with bladder cuff excision and regional lymphadenectomy on the affected side; (2) Have claustrophobia or other conditions that preclude completion of the examination; (3) Patients with alcohol or drug abuse, or those with mental disorders who are unable to cooperate; (4) Concurrent diagnosis of other malignant tumors; (5) Poor general condition that prevents completion of PET/CT examination or inability to tolerate surgery; (6) Mental abnormalities or intellectual disability with poor compliance, resulting in inability to cooperate with examinations and treatment; (7) Women who are pregnant, lactating, or planning to become pregnant within six months; (8) Other circumstances deemed by the clinical trial personnel as inappropriate for participation in this trial.

Design outcomes

Primary

MeasureTime frame
diagnostic sensitivity;diagnostic specificity;

Countries

China

Contacts

Public ContactJianye Liu

The Third Xiangya Hospital of Central South University

liujianye810@163.com+86 735 8861 8828

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026