Trials / Completed
CompletedNCT05861778
Evaluation of 89Zr-TLX250 PET/CT in Chinese Patients With Indeterminate Renal Masses or Suspected Recurrent Renal Clear Cell Carcinoma
An Open-label, Phase I Study to Evaluate the Safety, Radiation Dosimetry and Pharmacokinetics of 89Zr-TLX250 PET/CT in Patients With Indeterminate Renal Masses or Suspected Recurrent Renal Clear Cell Carcinoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Telix Pharmaceuticals (Innovations) Pty Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study is designed to evaluate the safety, tolerability, radiation dosimetry and pharmacokinetics 89Zr-TLX250 (also known as 89Zr-DFO-girentuximab) Positron Emission Tomography/Computed Tomography (PET/CT) in adult Chinese patients with indeterminate renal masses or Suspected Recurrent Renal Clear Cell Carcinoma
Conditions
- Clear Cell Renal Cell Carcinoma
- Suspected Recurrent Renal Clear Cell Carcinoma
- Recurrent Renal Cell Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 89Zr-Girentuximab | A single administration of 37 MBq (±10%) 89Zr-TLX250, containing a mass dose of 10 mg of girentuximab, followed by whole body PET/CT scans were performed at 0.5h, 4h, 24h, 72 hours and 7±1 days post administration. |
Timeline
- Start date
- 2023-06-26
- Primary completion
- 2023-11-27
- Completion
- 2023-11-27
- First posted
- 2023-05-17
- Last updated
- 2023-12-11
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05861778. Inclusion in this directory is not an endorsement.