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AzTrials

Renal Cell Carcinoma (RCC)FAZANCT03955393

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

An observational study of Renal Cell Carcinoma (RCC), run by IRCCS San Raffaele at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma (RCC)
What is being tested?
18F-FAZA PET IMAGING TECHNIQUE IN DETECTING LYMPH NODE METASTASES IN RENAL CELL CARCINOMA PATIENTS
Type of treatment
Injection or infusion
How many people
20 participants
Where
1 siteItaly
Study dates
Sep 2016to 30 Sep 2019
How long will I take part?
3 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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;
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  • 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

Who cannot join

  • 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;
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  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • IRCCS San Raffaele

    Milan, 20132

Other trials in Italy

About this study

Official title: THE ROLE OF 18F-FAZA PET IMAGING TECHNIQUE 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.

Being tested
18F-FAZA PET IMAGING TECHNIQUE IN DETECTING LYMPH NODE METASTASES IN RENAL CELL CARCINOMA PATIENTS
Keywords
LYMPH NODE METASTASES, 18F-FAZA PET IMAGING TECHNIQUE
Medical subject headings
Carcinoma, Renal Cell, Lymphatic Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called 18F-FAZA

    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.

Study groups in NCT03955393
Study groupRoleWhat they receive
LYMPH NODE METASTASES IN RENAL CELL CARCINOMA PATIENTSTwenty 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.
Receives: Other: 18F-FAZA PET IMAGING TECHNIQUE IN DETECTING LYMPH NODE METASTASES IN RENAL CELL CARCINOMA PATIENTS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Test the performance of 18F-FAZA

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

    Measured: 120 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2019
  2. Study startSep 2016
  3. Primary completionApr 2019
  4. Study completion30 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
20 participants (actual)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03955393
Sponsor's protocol ID
FAZA RCC LNI
Acronym
FAZA
Status last verified
Dec 2020
First submitted
16 May 2019
Last updated
22 Dec 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 20633979

  • 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.

    PubMed 21940096

  • 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. doi: 10.1016/s0022-5347(17)39422-3.

    PubMed 2374186

  • 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.

    PubMed 19824083

  • 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.

    PubMed 11435825

  • 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.

    PubMed 19157687

  • 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.

    PubMed 21056534

  • Blom JH, van Poppel H, Marechal JM, Jacqmin D, Schroder 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.

    PubMed 18848382

  • 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.

    PubMed 21233186

  • Studer UE, Birkhauser 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. No abstract available.

    PubMed 18848383

  • Capitanio U, Pepe G, Incerti E, Larcher A, Trevisani F, Luciano 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.

    PubMed 32638098

Questions about this trial

What is this clinical trial studying?

An observational study of Renal Cell Carcinoma (RCC), run by IRCCS San Raffaele at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Test the performance of 18F-FAZA (time frame: 120 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03955393, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.

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