THE ROLE OF 18F-FAZA PET IN DETECTING LYMPH NODE METASTASES IN PATIENTS WITH KIDNEY TUMOR

THE ROLE OF 18F-FAZA PET IMAGING TECHNIQUE IN DETECTING LYMPH NODE METASTASES IN RENAL CELL CARCINOMA PATIENTS - FAZA RCC LNI

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001774-15-IT

Enrollment

Unknown

Registered

2021-06-08

Start date

2017-02-09

Completion date

Unknown

Last updated

2021-07-12

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

Conditions

kidney cancer MedDRA version: 20.1 Level: LLT Classification code 10023400 Term: Kidney cancer System Organ Class: 100000004864

Interventions

Product Name: 1-(5-Deoxy-5-fluoro-a-D-arabinofuranosil)-2-nitroimidazolo Product Code: [18F]FAZA Pharmaceutical Form: Solution for injection Current Sponsor code: FAZA Other descriptive name: FAZA Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -adults (age>18yrs) affected by renal cell carcinoma (any subtype) with or without sarcomatous features -candidates for nephrectomy and lymph node dissection -cT4 mass or tumor diameter >10 cm or lymphadenopathies (cN1) -negative pregnancy test in case of woman in pregnancy age -to be able to understand the informed consent -the informed consent must be accepted and signed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

Exclusion criteria: -neoadjuvant therapy with TKI or MTOR-i -pregnancy and breast feeding -females in pregancy age and no contraceptive use -ECOG>1 -eGFR<30 or Child-Pugh B or C or NYHA III-IV

Design outcomes

Primary

Measure	Time frame
Main Objective: To test the accuracy of FAZA TC-PET in identifying lymph node metastases in patients with kidney cancer;Secondary Objective: To evaluate and to quantify tracer uptake in primary kdney tumor and in lymph node and distant metastases, as well;Primary end point(s):	—

Countries

Italy

Contacts

Public Contacturologia

Ospedale San Raffaele - Milano

umbertocapitanio@gmail.com02.2643.7286

Outcome results

None listed

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