Patients with an indeterminate renal mass (IRM) detected on contrast-enhanced abdominal MR imaging or equivalent standard of care imaging, clinically suspicious for renal cell carcinoma and scheduled for lesion resection as part of the regular diagnostic work-up/clinical care.
Conditions
Interventions
Product Name: 89Zr-TLX250 (synonyms: 89Zr-girentuximab, 89Zr-DFO-TFP-GTX)
Product Code: 89Zr-TLX250
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: GIRENTUXIMAB / G250
Current Sponsor
Sponsors
TELIX International Pty Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients must meet all of the following criteria: 1. Written and voluntarily given informed consent 2. Male or female = 18 years of age 3. Imaging evidence of a single indeterminate renal mass of = 7 cm in largest diameter (tumour stage cT1) on standard of care 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 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. For patients included in France only, verification and confirmation of their affiliation with a social security 7. Sufficient life expectancy to justify nephrectomy. 8. Consent to practise highly effective contraception until a minimum of 42 days after 89Zr-TLX250 administration. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 168 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 84
Exclusion criteria
Exclusion criteria: A patient will be excluded from participation in the trial if one or more of the following criteria are met: 1. A biopsy procedure only (rather than partial or total nephrectomy) 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. Chemotherapy, radiotherapy, 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). 5. Planned antineoplastic therapies (for the period between administration of 89Zr-TLX250 and imaging). 6. Exposure to murine or chimeric antibodies within the last 5 years. 7. Previous administration of any radionuclide within 10 half-lives of the same 8. 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 subject, as judged by the investigator 9. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study. 10. Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr TLX250 11. Women who are pregnant or breastfeeding. 12. Known hypersensitivity to girentuximab or DFO (desferoxamine) 13. Renal insufficiency with GFR = 45 mL/min/ 1.73 m² 14. Vulnerable patients (e.g. being in detention)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate sensitivity and specificity of qualitative assessment of PET/CT imaging with 89Zr-TLX250 to non-invasively detect ccRCC in patients with indeterminate renal masses, using histology as standard of truth. ;Secondary Objective: 1. To determine sensitivity and specificity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in the subgroup of patients with indeterminate renal masses of = 4 cm in largest diameter (cT1a) 2. To determine positive predictive value (PPV), negative predictive value (NPV), and accuracy of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses, and in the subgroup of patients with indeterminate renal masses of = 4 cm (cT1a) 3. To identify a standardized uptake value (SUV) cut-off for 89Zr TLX250, suitable to discriminate ccRCC from non-ccRCC 4. To determine inter-reader variability of diagnostic assessments of 89Zr-TLX250 PET/CT images, when performed by multiple readers 5. To determine intra-reader variability of diagnostic assessment of 89Zr-TLX250 PET/CT images 6. To establish safety and tolerability of 89Zr-TLX250 in patients with indeterminate renal masses. ;Primary end point(s): The primary study objective is to evaluate the diagnostic efficacy of 89Zr-TLX250 as a non-invasive diagnostic tool for the detection of clear cell renal carcinoma. ;Timepoint(s) of evaluation of this end point: Treatment: IMP administered on Day 0 Imaging visit: Day 5 ± 2 days (PET/CT imaging) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Test performance parameters (sensitivity, specificity, positive and negative predictive values, accuracy), will be determined considering visually determined qualitatitive 89Zr-TLX250 tumour uptake (yes/no), and histology (ccRCC+/ ccRCC-) as standard of truth. ;Timepoint(s) of evaluation of this end point: Treatment: IMP administered on Day 0 Imaging visit: Day 5 ± 2 days (abdominal PET/CT imaging) Surgery visit: any time after imaging visit, but no later than Day 90 p.a. (Surgical resection material will be sent to local pathology for routine histological work-up (H&E staining, histological diagnosis: ccRCC vs. non-ccRCC). Central pathology service, for independent confirmation of histological diagnosis. In addition, CAIX expression. | — |
Countries
Australia, Belgium, Canada, France, Netherlands, Spain, Turkey, United Kingdom, United States
Contacts
Public Contactclinical trials information
ABX-CRO advanced pharmaceutical services
Outcome results
None listed