Find Renal Cell Carcinoma (RCC) Clinical Trials Near You
A Confirmatory, Open-label, Single-arm, Multi-centre Study to Evaluate Safety, Tolerability and Diagnostic Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) to Non-invasively Detect Clear Cell Renal Cell Carcinoma (ccRCC) by Positron Emission Tomography/Computed Tomography (PET/CT) Imaging in Chinese Patients With Indeterminate Renal Masses (ZIRCON-CP Study)
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma, and this Phase 3 bridging study in mainland Chinese patients is intended to support the successful ZIRCON data (ZIRCON Clinicaltrial.gov ID: NCT03849118)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Written and voluntarily given informed consent.
• Mainland Chinese male or female, aged ≥ 18 years.
• Imaging evidence of a single IRM of ≤ 7 cm in largest diameter (tumour stage cT1), on SoC imaging based on national standards, not older than 90 days on Day 0, but performed before any screening procedure.
• Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned IV 89Zr-TLX250 administration.
• Negative serum pregnancy tests in female patients of childbearing potential at screening. Confirmation of negative pregnancy test result from urine within 24 hours prior to receiving investigational product.
• Sufficient life expectancy to justify nephrectomy.
• Consent to practise highly effective contraception until a minimum of 42 days after IV 89Zr-TLX250 administration.
Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Zhejiang Provincial People's Hospital
NOT_YET_RECRUITING
Hangzhou
Union Hospital Tongji Medical College Huazhong University Of Science And Technology
NOT_YET_RECRUITING
Hubei
Zhongshan Hospital, Fudan University
NOT_YET_RECRUITING
Shanghai
The First Affiliated Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
Tianjin Cancer Hospital Airport Hospital
NOT_YET_RECRUITING
Tianjin
Affiliated Hospital Of Jiangnan University
NOT_YET_RECRUITING
Wuxi
Zhejiang Cancer Hospital
NOT_YET_RECRUITING
Zhejiang
Contact Information
Primary
Lily Nahidi
lily.nahidi@telixpharma.com
+61 3909 33871
Time Frame
Start Date:2024-11-06
Estimated Completion Date:2026-06-30
Participants
Target number of participants:82
Treatments
Experimental: Experimental arm receiving the IP
Approximately 82 evaluable adult patients will be recruited from approximately 8 renal cancer care specialist centres with access to state-of-the-art PET/CT imaging in mainland China. The number of enrolled participants may be increased to ensure sufficient confidence in measuring sensitivity and specificity of 89Zr-TLX250 PET/CT imaging.~Following pre-screen morphological imaging to confirm evidence of IRM (to occur within 90 days of study enrolment), participants will attend a screening visit within 30 days of study enrolment, at which time baseline examinations will be undertaken.~On Day 0, all successfully screened participants will undergo a slow IV administration of 89Zr- TLX250, at the nuclear medicine service of the respective study site. For all subjects, a PET/CT scan of the abdomen will occur on visit Day 5 (±2 days post administration \[p.a.\]) with nephrectomy to be performed any time after the PET/CT imaging visit, but no later than 90 days p.a. 89Zr-TLX250.