Diagnosis of clear cell renal cell carcimona in patients with unidentified renal masses Cancer
Conditions
Interventions
Current interventions as of 10/02/2025:
Eligible patients will be enrolled in one of the three groups, which will enrol in parallel. At the discretion of the investigator and in consultation with th
Sponsors
Telix International Pty Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 10/02/2025: 1. Patients =18 years of age at time of informed consent signature 2. Have morphological imaging evidence of a single renal mass of =7 cm in largest diameter on standard of care (SoC) imaging (CT/MRI) based on national standards, requiring further diagnostic work-up, including participants who have simple cysts (Bosniak I to II) in addition to the single indeterminate renal mass and participants with suspected recurrence based on previous imaging. Patients with a history of ccRCC and renal lesion of unclear origin during follow-up may also be included 3. Life expectancy of at least 6 months 4. Availability of a pre-study morphological image (contrast-enhanced CT or MRI scan) showing a renal mass within 90 days prior to dosing with 89Zr-DFO-girentuximab. 5. Have the capacity to understand the study and be willing and able to comply with all protocol requirements. 6. Negative serum pregnancy tests in female patients of child-bearing potential at screening. Confirmation of negative pregnancy test results from urine within 24 hours prior to receiving investigational product. 7. Participants must agree to practice adequate precautions to prevent pregnancy, including male patients with female of child-bearing potential partners and to avoid potential problems associated with radiation exposure to the unborn child (Refer to 10.2, Appendix 2). 8. Participants must comply with the radiation protection rules that are used by the treating institution in order to protect their close contacts and the general public. 9. Participant agrees not to participate in another interventional study while participating in the present study. _____ Previous inclusion criteria: 1. Patients =18 years of age at time of informed consent signature 2. Have morphological imaging evidence of a single renal mass of =7 cm in largest diameter on standard of care (SoC) imaging (CT/MRI) based on national standards, requiring further diagnostic work-up a. Patients with a history of ccRCC and renal lesion of unclear origin during follow-up may also be included 3. Life expectancy of at least 6 months 4. Availability of a pre-study morphological image (contrast-enhanced CT or MRI scan) showing a renal mass within 90 days prior to dosing with 89Zr-DFO-girentuximab. 5. Have the capacity to understand the study and be willing and able to comply with all protocol requirements. 6. Negative serum pregnancy tests in female patients of child-bearing potential at screening. Confirmation of negative pregnancy test results from urine within 24 hours prior to receiving investigational product. 7. Participants must agree to practice adequate precautions to prevent pregnancy, including male patients with female of child-bearing potential partners and to avoid potential problems associated with radiation exposure to the unborn child (Refer to 10.2, Appendix 2). 8. Participants must comply with the radiation protection rules that are used by the treating institution in order to protect their close contacts and the general public. 9. Participant agrees not to participate in another interventional study while participating in the present study.
Exclusion criteria
Exclusion criteria: 1. Other radiopharmaceutical administered within ten physical half-lives (of the radionuclide) of intended administration of 89Zr-DFO-girentuximab (i.e., within ten physical half-lives of Day 0) 2. Exposure to any experimental diagnostic or therapeutic agent within 30 days of planned administration of 89Zr-DFO-girentuximab (i.e., within 30 days of day 0). 3. Known uncontrolled hyperthyroidism. 4. Any planned antineoplastic therapies to be administered between administration of 89Zr-DFO-girentuximab and imaging. 5. Established diagnosis of renal cell carcinoma in the renal mass 6. Any clinically significant abnormalities detected during screening blood tests or physical exam that in the opinion of the investigator would adversely affect the participants’ ability to participate in the study. 7. Known allergy, hypersensitivity, or intolerance to girentuximab or any of the components of the investigational agent. 8. Psychiatric, cognitive, or other condition that, in the opinion of the investigator, compromises full compliance with the requirements of the study. 9. Women who are pregnant or breast-feeding 10. Exposure to murine or chimeric antibodies within the last 5 years 11. Serious but non life-threatening diseases or any other health conditions which the investigator determines may impact patient safety, compliance, and the integrity of the study data. 12. Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the planned administration of 89Zr-DFO-girentuximab or continuing adverse effects (> Grade 1) from such therapy (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0). 13. Planned antineoplastic therapies (for the period between IV administration of 89Zr-DFO-girentuximab and imaging) 14. Known hypersensitivity to girentuximab or DFO. 15. Renal insufficiency with GFR = 45 mL/min/ 1.73 m²
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety and tolerability will be measured by comparing all the adverse events between patients treated with IMP containing girentuximab derived from ADRM-free medium versus patients treated with IMP containing girentuximab derived from ADRM-containing medium, at the end of the study. 2. Equivalence of uptake will be measured by comparing the injected activity (as a percentage) per organ mass in the major target organs including kidneys, liver, spleen, heart content and red marrow at the end of the study patients treated with IMP containing girentuximab derived from ADRM-free medium versus patients treated with IMP containing girentuximab derived from ADRM-containing medium, at the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Radiation Pharmacokinetics (PK) will be measured by comparing the following between patients treated with IMP containing girentuximab derived from ADRM-free medium versus patients treated with IMP containing girentuximab derived from ADRM-containing medium, at the end of the study. 1.1. Whole blood radiation PK measurements will include Cmax, Tmax, elimination half-live (T1/2), volume of distribution, and Area under the Curve (AUC0-inf) calculated from the radiation PK measurements 1.2. Radioactivity uptake in tumor lesions including SUVpeak, SUVmax and SUVmean, Time Activity Curve, and Time Integrated Activity Coefficient calculated from the PET/CT images 1.3. 89Zr retention on the tumour by AUC0-inf obtained from the images calculated from the PET/CT images 1.4. Tumour to background ratio during imaging on days 0, 1, 3 and 6 calculated from the PET/CT images 1.5. Radioactivity uptake in major target organs calculated from the PET/CT images 1.6. Normalized whole body effective radiation calculated from the PET/CT images 1.7. Normalized absorbed organ and tumor radiation calculated from the PET/CT images 2. Patient safety will be measured by comparing the following between patients treated with IMP containing girentuximab derived from ADRM-free medium versus patients treated with IMP containing girentuximab derived from ADRM-containing medium, at the end of the study. 2.1. Serious Adverse Events 2.2. Changes in safety laboratory assessments that are clinically significant 2.3. Changes in ECG parameters that are clinically significant 2.4. Changes in physical examination results that are clinically significant 2.5. Changes in vital signs that are clinically significant | — |
Countries
Australia, New Zealand
Contacts
Public ContactBrenda Cerqueira
Outcome results
None listed