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

Phase 1

• Conditions: kidney cancer; MedDRA version: 20.1Level: LLTClassification code 10023400Term: Kidney cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001774-15-IT
• Lead Sponsor: OSPEDALE SAN RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified