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

Sponsor
IRCCS San Raffaele (Other)
Overall Status
Completed
CT.gov ID
NCT03955393
Collaborator
(none)
20
Enrollment
1
Location
36.9
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 18F-FAZA PET IMAGING TECHNIQUE IN DETECTING LYMPH NODE METASTASES IN RENAL CELL CARCINOMA PATIENTS

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
20 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
THE ROLE OF 18F-FAZA PET IMAGING TECHNIQUE IN DETECTING LYMPH NODE METASTASES IN RENAL CELL CARCINOMA PATIENTS
Actual Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Apr 1, 2019
Actual Study Completion Date :
Sep 30, 2019

Arms and Interventions

Arm Intervention/Treatment
LYMPH NODE METASTASES IN RENAL CELL CARCINOMA PATIENTS

Twenty patients candidates to radical nephrectomy and extended lymphadenectomy for clinical T4 cancers (clinical Nany) or renal masses with evidence of lymphadenopathies at preoperative CT scan (clinical Tany N1) or larger tumor (clinical Tany Nany and max diameter>10 cm). RCC candidates to surgery will receive a single intravenous infusion of 18F-FAZA. Surgery will be scheduled within 1 week after infusion. PET and CT scanning of the abdomen will be planned before surgery.

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Test the performance of 18F-FAZA [120 minutes]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCCS San Raffaele Milan Italy 20132

    Sponsors and Collaborators

    • IRCCS San Raffaele

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Umberto Capitanio, Principal Investigator, IRCCS San Raffaele
    ClinicalTrials.gov Identifier:
    NCT03955393
    Other Study ID Numbers:
    • FAZA RCC LNI
    First Posted:
    May 20, 2019
    Last Update Posted:
    Dec 22, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Umberto Capitanio, Principal Investigator, IRCCS San Raffaele
    LYMPH NODE METASTASES
    18F-FAZA PET IMAGING TECHNIQUE
    Additional relevant MeSH terms:
    Carcinoma
    Neoplasm Metastasis
    Carcinoma, Renal Cell
    Lymphatic Metastasis
    Fluoroazomycin arabinoside

    Study Results

    No Results Posted as of Dec 22, 2020