Actively Recruiting
89Zr-TLX250 for PET/CT Imaging of ccRCC - ZIRCON-CP Study
Led by Telix Pharmaceuticals (Innovations) Pty Limited · Updated on 2024-12-27
82
Participants Needed
8
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
89Zr-TLX250 for PET/CT Imaging of ccRCC - ZIRCON-CP Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- A biopsy procedure only (rather than partial or total nephrectomy) is planned for histological species delineation of IRM.
- Renal mass known to be a metastasis of another primary tumour.
- Active non-renal malignancy requiring therapy during the time frame of the study participation.
- Multiple unilateral or bilateral IRM.
- Chemotherapy, radiotherapy, targeted therapy or immunotherapy within 4 weeks prior to the planned administration of 89Zr -TLX250 or continuing adverse effects (> grade 1) from such therapy (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0).
- Planned antineoplastic therapies (for the period between IV administration of 89Zr-TLX250 and imaging).
- Exposure to murine or chimeric antibodies within the last 5 years.
- Previous administration of any radionuclide within 10 half-lives of the same.
- Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic), that may interfere with the objectives of the study or with the safety or compliance of the study subject, as judged by the investigator.
- Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
- Exposure to any experimental diagnostic or therapeutic drug within 4 weeks or 5 half-lives (whichever is longer) from the date of planned administration of 89Zr-TLX250.
- Women who are pregnant or breastfeeding.
- Known hypersensitivity to girentuximab or desferoxamine (DFO).
- Renal insufficiency with glomerular filtration rate (GFR) ≤ 45 mL/min/1.73 m².
- Vulnerable patients (e.g., being in detention).
AI-Screening
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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
Research Team
L
Lily Nahidi
CONTACT
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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