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出境医 / 临床实验 / FAZA PET IMAGING IN DETECTING LYMPH NODE METASTASES IN RENAL CELL CARCINOMA PATIENTS (FAZA)

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

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
Renal Cell Carcinoma (RCC) Other: 18F-FAZA PET IMAGING TECHNIQUE IN DETECTING LYMPH NODE METASTASES IN RENAL CELL CARCINOMA PATIENTS

Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: THE ROLE OF 18F-FAZA PET IMAGING TECHNIQUE IN DETECTING LYMPH NODE METASTASES IN RENAL CELL CARCINOMA PATIENTS
Actual Study Start Date : September 2016
Actual Primary Completion Date : April 2019
Actual Study Completion Date : September 30, 2019
Arms and Interventions
Group/Cohort 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 Name: 18F-FAZA
Outcome Measures
Primary Outcome Measures :
  1. 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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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).
Criteria

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
Layout table for location information
Italy
IRCCS San Raffaele
Milan, Italy, 20132
Sponsors and Collaborators
IRCCS San Raffaele
Tracking Information
First Submitted Date May 16, 2019
First Posted Date May 20, 2019
Last Update Posted Date December 22, 2020
Actual Study Start Date September 2016
Actual Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 16, 2019) 		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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title FAZA PET IMAGING IN DETECTING LYMPH NODE METASTASES IN RENAL CELL CARCINOMA PATIENTS
Official Title THE ROLE OF 18F-FAZA PET IMAGING TECHNIQUE IN DETECTING LYMPH NODE METASTASES IN RENAL CELL CARCINOMA PATIENTS
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 3 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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).
Condition Renal Cell Carcinoma (RCC)
Intervention 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 Name: 18F-FAZA
Study Groups/Cohorts 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.
Intervention: Other: 18F-FAZA PET IMAGING TECHNIQUE IN DETECTING LYMPH NODE METASTASES IN RENAL CELL CARCINOMA PATIENTS
Publications *
  • Ljungberg B, Cowan NC, Hanbury DC, Hora M, Kuczyk MA, Merseburger AS, Patard JJ, Mulders PF, Sinescu IC; European Association of Urology Guideline Group. EAU guidelines on renal cell carcinoma: the 2010 update. Eur Urol. 2010 Sep;58(3):398-406. doi: 10.1016/j.eururo.2010.06.032. Epub 2010 Jul 12.
  • Capitanio U, Becker F, Blute ML, Mulders P, Patard JJ, Russo P, Studer UE, Van Poppel H. Lymph node dissection in renal cell carcinoma. Eur Urol. 2011 Dec;60(6):1212-20. doi: 10.1016/j.eururo.2011.09.003. Epub 2011 Sep 13. Review.
  • Studer UE, Scherz S, Scheidegger J, Kraft R, Sonntag R, Ackermann D, Zingg EJ. Enlargement of regional lymph nodes in renal cell carcinoma is often not due to metastases. J Urol. 1990 Aug;144(2 Pt 1):243-5.
  • Lughezzani G, Capitanio U, Jeldres C, Isbarn H, Shariat SF, Arjane P, Widmer H, Perrotte P, Montorsi F, Karakiewicz PI. Prognostic significance of lymph node invasion in patients with metastatic renal cell carcinoma: a population-based perspective. Cancer. 2009 Dec 15;115(24):5680-7. doi: 10.1002/cncr.24682.
  • Vasselli JR, Yang JC, Linehan WM, White DE, Rosenberg SA, Walther MM. Lack of retroperitoneal lymphadenopathy predicts survival of patients with metastatic renal cell carcinoma. J Urol. 2001 Jul;166(1):68-72.
  • Stenzl A, Cowan NC, De Santis M, Jakse G, Kuczyk MA, Merseburger AS, Ribal MJ, Sherif A, Witjes JA. The updated EAU guidelines on muscle-invasive and metastatic bladder cancer. Eur Urol. 2009 Apr;55(4):815-25. doi: 10.1016/j.eururo.2009.01.002. Epub 2009 Jan 13. Review.
  • Heidenreich A, Bellmunt J, Bolla M, Joniau S, Mason M, Matveev V, Mottet N, Schmid HP, van der Kwast T, Wiegel T, Zattoni F; European Association of Urology. EAU guidelines on prostate cancer. Part 1: screening, diagnosis, and treatment of clinically localised disease. Eur Urol. 2011 Jan;59(1):61-71. doi: 10.1016/j.eururo.2010.10.039. Epub 2010 Oct 28.
  • Blom JH, van Poppel H, Maréchal JM, Jacqmin D, Schröder FH, de Prijck L, Sylvester R; EORTC Genitourinary Tract Cancer Group. Radical nephrectomy with and without lymph-node dissection: final results of European Organization for Research and Treatment of Cancer (EORTC) randomized phase 3 trial 30881. Eur Urol. 2009 Jan;55(1):28-34. doi: 10.1016/j.eururo.2008.09.052. Epub 2008 Oct 1.
  • Beyer T, Czernin J, Freudenberg LS. Variations in clinical PET/CT operations: results of an international survey of active PET/CT users. J Nucl Med. 2011 Feb;52(2):303-10. doi: 10.2967/jnumed.110.079624. Epub 2011 Jan 13.
  • Studer UE, Birkhäuser FD. Lymphadenectomy combined with radical nephrectomy: to do or not to do? Eur Urol. 2009 Jan;55(1):35-7. doi: 10.1016/j.eururo.2008.09.056. Epub 2008 Oct 7.
  • Capitanio U, Pepe G, Incerti E, Larcher A, Trevisani F, Lucianò R, Mapelli P, Bettinardi V, Monterisi C, Necchi A, Cascinu S, Bernardi R, Bertini R, Doglioni C, Gianolli L, Salonia A, Picchio M, Montorsi F. The role of 18F-FAZA PET/CT in detecting lymph node metastases in renal cell carcinoma patients: a prospective pilot trial. Eur J Nucl Med Mol Imaging. 2021 Feb;48(2):554-560. doi: 10.1007/s00259-020-04936-2. Epub 2020 Jul 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 16, 2019) 		20
Original Actual Enrollment Same as current
Actual Study Completion Date September 30, 2019
Actual Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03955393
Other Study ID Numbers FAZA RCC LNI
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Umberto Capitanio, IRCCS San Raffaele
Study Sponsor IRCCS San Raffaele
Collaborators Not Provided
Investigators Not Provided
PRS Account IRCCS San Raffaele
Verification Date December 2020

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