Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID06750419

Study of 89Zr-TLX250 PET/CT Imaging to Detect Clear Cell Renal Cell Carcinoma in Patients with Indeterminate Renal Masses Evaluating Safety, Tolerability, and Diagnostic Accuracy

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  1. Written and voluntarily given informed consent.
  2. Mainland Chinese male or female, aged ≥ 18 years.
  3. 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.
  4. Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned IV 89Zr-TLX250 administration.
  5. 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.
  6. Sufficient life expectancy to justify nephrectomy.
  7. Consent to practise highly effective contraception until a minimum of 42 days after IV 89Zr-TLX250 administration.
Not Eligible

You will not qualify if you...

  1. A biopsy procedure only (rather than partial or total nephrectomy) is planned for histological species delineation of IRM.
  2. Renal mass known to be a metastasis of another primary tumour.
  3. Active non-renal malignancy requiring therapy during the time frame of the study participation.
  4. Multiple unilateral or bilateral IRM.
  5. 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).
  6. Planned antineoplastic therapies (for the period between IV administration of 89Zr-TLX250 and imaging).
  7. Exposure to murine or chimeric antibodies within the last 5 years.
  8. Previous administration of any radionuclide within 10 half-lives of the same.
  9. 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.
  10. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
  11. 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.
  12. Women who are pregnant or breastfeeding.
  13. Known hypersensitivity to girentuximab or desferoxamine (DFO).
  14. Renal insufficiency with glomerular filtration rate (GFR) ≤ 45 mL/min/1.73 m².
  15. Vulnerable patients (e.g., being in detention).

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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

Frequently Asked Questions

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Published Research Related To This Trial

[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/39270701

ImmunoPET imaging of renal cell carcinoma with (124)I- and (89)Zr-labeled anti-CAIX monoclonal antibody cG250 in mice.

Alexander B Stillebroer, Gerben M Franssen, Peter F A Mulders...

https://pubmed.ncbi.nlm.nih.gov/23697926

Phase 1 radioimmunotherapy study with lutetium 177-labeled anti-carbonic anhydrase IX monoclonal antibody girentuximab in patients with advanced renal cell carcinoma.

Alexander B Stillebroer, Otto C Boerman, Ingrid M E Desar...

https://pubmed.ncbi.nlm.nih.gov/22980441

Tumor retention of 186Re-MAG3, 111In-DTPA and 125I labeled monoclonal antibody G250 in nude mice with renal cell carcinoma xenografts.

M G Steffens, M H Kranenborg, O C Boerman...

https://pubmed.ncbi.nlm.nih.gov/10850349

Incidence of benign lesions for clinically localized renal masses smaller than 7 cm in radiological diameter: influence of sex.

Mark E Snyder, Ariadne Bach, Michael W Kattan...

https://pubmed.ncbi.nlm.nih.gov/17085108