FAZA PET IMAGING IN DETECTING LYMPH NODE METASTASES IN RENAL CELL CARCINOMA PATIENTS

In renal cell carcinoma (RCC) patients, lymph node metastases detection and treatment are the most critical issues in daily clinical decision-making. Indeed, conversely to other oncological settings, a) nodal status imaging, b) sentinel node technique and c) standard lymphadenectomy have been demonstrated inadequate in the staging and management of RCC patients. A novel, accurate, standardized imaging technique is urgently needed in RCC setting to detect macro and micro nodal invasion, to identify those patients who are at higher risk of having nodal metastases, to accurately plan the best management. Recent studies suggested combining 18F-FAZA PET with CT scanning in the detection of cancer-induced hypoxia.The investigators propose to test 18F-FAZA PET-CT in detecting nodal metastases to improve the management of RCC patients.

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Key information

Conditions

Renal Cell Carcinoma (RCC) Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Lymphatic Metastasis Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS San Raffaele

Milan, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

age of at least 18 years with diagnosis of RCC;
patients candidates to radical nephrectomy and extended lymphadenectomy
clinical T4 cancers or renal masses with evidence of lymphadenopathies at preoperative CT scan or larger tumor (max diameter>10 cm)
performance status 0-1;
expected survival time of at least 3 months;
recovery from toxic effects of any previous treatment;
serum biochemical and haematological measurements within healthy parameters.
Female patients of childbearing age were requested to have a negative pregnancy test
ability to understand and understand informed consent
acceptance and signature of informed consent

Exclusion criteria

other medical conditions that might limit the amount of antibody to be administered;
New York Heart Association Class III/IV cardiac disease;
pregnancy and breastfeeding
eGFR<30;
women of child-bearing age who do not agree to use contraceptives to avoid pregnancy;
history of autoimmune hepatitis;
allergy to iodine;
unavailability or immunological and clinical follow-up assessments;
participation in another clinical trial involving an investigational agent within 4 weeks of study enrolment

Treatment and study plan

18F-FAZA PET IMAGING TECHNIQUE IN DETECTING LYMPH NODE METASTASES IN RENAL CELL CARCINOMA PATIENTS

Other

18F-FAZA is a highly selective PET radiotracer of hypoxia, which has been recently developed and tested in several studies (10-14). 18F-FAZA has been demonstrated to be a marker of hypoxia and pathological metabolic patterns which are common to all renal cancers.

Other names: 18F-FAZA

Primary outcomes

Test the performance of 18F-FAZA

Time frame: 120 minutes

To test the performance of 18F-FAZA PET technique in detecting nodal metastases in RCC patients

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Acronym: FAZA

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: May 20, 2019
Registry last updated: Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed