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

Renal Cell Carcinoma (RCC) Clinical Trial

— FAZA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03955393
• Other study ID #: FAZA RCC LNI
• Status: Completed
• Start date: September 2016
• Est. completion date: September 30, 2019

Study information

• Verified date: December 2020
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 30, 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Neoplasm Metastasis
• 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.

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. 2020 Jul 8. doi: 10.1007/s00259-020-04936-2. [Epub ahead of print] — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test the performance of 18F-FAZA	To test the performance of 18F-FAZA PET technique in detecting nodal metastases in RCC patients	120 minutes