[89Zr]Zr-girentuximab for PET-CT imaging of clear-cell renal cell carcinoma: a prospective, open-label, multicentre, phase 3 trial.
Brian Shuch, Allan J Pantuck, Jean-Christophe Bernhard...
https://pubmed.ncbi.nlm.nih.gov/39270701Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID06750419
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 PET/CT Imaging in Chinese Patients With Indeterminate Renal Masses
Led by Telix Pharmaceuticals (Innovations) Pty Limited · Updated on 2024-12-27
82
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying 89Zr-TLX250, a diagnostic imaging agent, to detect clear cell renal cell carcinoma (ccRCC) in Chinese patients with indeterminate renal masses. This Phase 3, open-label, single-arm study aims to confirm the safety, tolerability, sensitivity, and specificity of 89Zr-TLX250 PET/CT imaging. The study supports prior ZIRCON trial data and involves adult patients scheduled for partial or total nephrectomy as part of their standard care. Participants will receive a single intravenous dose of 37 MBq of 89Zr-TLX250 containing 10 mg of girentuximab. Imaging of the abdomen using PET/CT will be performed 5 days post-administration, with possible whole-body imaging if widespread disease is suspected. Nephrectomy will occur any time after imaging but within 90 days. Histological analysis of tumor samples will confirm diagnosis. The study includes approximately seven visits over 4 to 6 months. Assessments include baseline exams, PET/CT imaging, surgery, and follow-up visits. Imaging and histological data will be centrally analyzed to evaluate diagnostic accuracy. Safety and tolerability will be monitored throughout. The study is expected to last about 12 months with 4 months of follow-up per participant.
CONDITIONS
Brief Title
89Zr-TLX250 for PET/CT Imaging of ccRCC - ZIRCON-CP Study
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Mainland Chinese male or female aged 18 years or older
- Imaging shows a single indeterminate renal mass 7 cm or smaller, done within 90 days before study start
- Scheduled for partial or total nephrectomy within 90 days after 89Zr-TLX250 administration
- Negative serum pregnancy test for women of childbearing potential at screening and urine test within 24 hours before study drug
- Life expectancy sufficient to justify nephrectomy
- Agree to use highly effective contraception until at least 42 days after study drug administration
You will not qualify if you...
- Only biopsy planned instead of partial or total nephrectomy
- Renal mass known to be metastasis from another primary tumor
- Active non-renal cancer requiring treatment during study participation
- Multiple indeterminate renal masses on one or both kidneys
- Chemotherapy, radiotherapy, targeted therapy, or immunotherapy within 4 weeks before study drug or ongoing significant side effects from such treatments
- Planned cancer treatments between study drug administration and imaging
- Exposure to murine or chimeric antibodies within last 5 years
- Previous radionuclide administration within 10 half-lives
- Serious non-cancer diseases affecting safety or study compliance
- Mental impairment affecting consent or study compliance
- Exposure to experimental drugs within 4 weeks or 5 half-lives before study drug
- Pregnant or breastfeeding women
- Known allergy to girentuximab or desferoxamine
- Kidney function with glomerular filtration rate 45 mL/min/1.73 m² or less
- Vulnerable individuals such as those in detention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - Up to 30 days
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Day 0 to Day 5 (±2 days)
Participants receive a single intravenous administration of 89Zr-TLX250 followed by PET/CT imaging to non-invasively detect clear cell renal cell carcinoma.
1 administration visit and 1 imaging visit
Surgery and Immediate Post-operative Care
Duration - Up to 90 days post imaging
Participants undergo partial or total nephrectomy as part of their standard care any time after PET/CT imaging, but no later than 90 days post 89Zr-TLX250 administration.
Surgery visit with timing depending on clinical schedule
Post-operative Follow-up
Duration - 35 to 42 days after surgery depending on timing of nephrectomy
Participants attend a final study visit for safety and diagnostic follow-up after nephrectomy.
1 follow-up visit (in-person)
Trial Site Locations
Total: 8 locations
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
2
Zhejiang Provincial People's Hospital
Hangzhou, China
Not Yet Recruiting
3
Union Hospital Tongji Medical College Huazhong University Of Science And Technology
Hubei, China
Not Yet Recruiting
4
Zhongshan Hospital, Fudan University
Shanghai, China
Not Yet Recruiting
5
The First Affiliated Hospital of Soochow University
Suzhou, China
Not Yet Recruiting
6
Tianjin Cancer Hospital Airport Hospital
Tianjin, China
Not Yet Recruiting
7
Affiliated Hospital Of Jiangnan University
Wuxi, China
Not Yet Recruiting
8
Zhejiang Cancer Hospital
Zhejiang, China
Not Yet Recruiting
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Research Team
L
Lily Nahidi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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