89Zr-TLX250 for PET/CT imaging of ccRCC (ZIRCON-study)
Research type
Research Study
Full title
A confirmatory, prospective, open-label, multi-centre phase 3 study to evaluate diagnostic performance of 89Zirconium-labelled girentuximab(89Zr-TLX250) to non-invasively detect clear cell renal cell carcinoma (ccRCC) by positron emission tomography/CT (PET/CT) imaging in patients with indeterminate renal masses (ZIRCON study)
IRAS ID
265881
Contact name
Thomas Wagner
Contact email
Sponsor organisation
Telix International Pty Ltd
Eudract number
2018-002773-21
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
Research Summary
This is a confirmatory, prospective, open-label, multi-centre phase 3 study to evaluate diagnostic performance of 89Zirconium-labelled girentuximab (89Zr-TLX250) to non-invasively detect clear cell renal cell carcinoma (ccRCC) by positron emission tomography/CT (PET/CT) imaging in patients with indeterminate renal masses (ZIRCON study).
The aims of this study is to:
To evaluate sensitivity and specificity of PET/CT imaging with 89Zr-TLX250 to non-invasively detect ccRCC in patients with indeterminate renal masses, using histology as standard of truth.
Approximately 15 – 25 centres in the EU (A, B, D, E, F, I, NL), Turkey, Australia and North America plan to enrol 252 subjects. 1 centre is plan in UK to enrol approximately 20 subjects.
The total duration of this study is anticipated to be approximately 12 months, including enrolment, treatment, and follow-up.
Summary of results
A clinical trial to evaluate diagnostic performance of 89Zirconium-labelled girentuximab(89Zr-TLX250) to non-invasively detect clear cell renal cell carcinoma (ccRCC) by positron emission tomography/CT (PET/CT) imaging in patients with indeterminate renal masses (ZIRCON study)
REC name
London - London Bridge Research Ethics Committee
REC reference
19/LO/1070
Date of REC Opinion
19 Aug 2019
REC opinion
Further Information Favourable Opinion