None listed
Conditions
Brief summary
This trial aims to evaluate the feasibility of using 89Zr-TLX250 PET/CT in the detection of localized and metastatic urothelial carcinoma or bladder cancer. Who is it for? You may be eligible for this trial if you are aged 18, able to provide informed consent, and histologically diagnosed with bladder cancer or urothelial carcinoma or known metastatic urothelial carcinoma or bladder cancer. Study details Participants will be screened through FDG PET/CT scan and baseline procedures (physical examination, general blood test, vital signs, medical and surgical history, and previous medications), within 28 days of selection to day 0). At day 0, participants will receive an injection of 89Zr-TLX250, followed by a diagnostic PET/CT scan on day 5 ± 2 days after 89Zr-TLX250 administration. Participants will be followed up at day 14 post-scan for a telephone consult regarding safety evaluation. It is hoped that information from this trial will help evaluate the effectiveness of 89Zr-TLX250 PET/CT in detecting primary bladder cancer and upper tract urothelial carcinoma.
Interventions
Patients with histopathologically diagnosed bladder cancer or urothelial carcinoma already being staged with Fluorodeoxyglucose (FDG) PET/CT or those with known FDG positive metastatic disease, who are willing to undergo an additional 89Zr-TLX250 PET/CT for the staging and detection of urothelial carcinoma and bladder cancer.
89Zr-TLX250, a chimeric monoclonal antibody (INN name: girentuximab (GTX), synonyms: cG250, TLX250) with specificity for the CAIX (carbonic anhydrase 9) antigen, radiolabe
Patients with histopathologically diagnosed bladder cancer or urothelial carcinoma already being staged with Fluorodeoxyglucose (FDG) PET/CT or those with known FDG positive metastatic disease, who are willing to undergo an additional 89Zr-TLX250 PET/CT for the staging and detection of urothelial carcinoma and bladder cancer. 89Zr-TLX250, a chimeric monoclonal antibody (INN name: girentuximab (GTX), synonyms: cG250, TLX250) with specificity for the CAIX (carbonic anhydrase 9) antigen, radiolabelled with the positron emitting radio-metal zirconium-89 via a NSuc-DFO-TFP-ester (DFO-TFP), linked to lysine residues of GTX, to yield 89Zr-DFO-TFP-GTX. 20 patients (10 patients with known metastatic urothelial carcinoma or bladder cancer and 10 patients who require primary staging of localized urothelial carcinoma or bladder cancer) will receive a single slow intravenous injection of 37 mBq (± 10%) 89Zr-TLX250, containing a mass dose of 10 mg of girentuximab over 3 minutes, followed by a diagnostic PET/CT scan on day 5 ± 2 days. Patients will be followed up at day 14 of post diagnostic 89Zr-TLX250 PET/CT scan. The 89Zr-TLX250 IV administration will be administered by a trained nuclear medicine physician or a nuclear medicine technician (guided by a nuclear medicine physician). The whole body 89Zr-TLX250 PET/CT will be acquired over a maximum of 45 minutes in 4 bed positions at a single time point on Day 5 ± 2 post administration of 89Zr-TLX250 using static image acquisition and low dose CT without contrast agent.
Sponsors
South Metropolitan Health Services
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged 18 or older with bladder cancer or urothelial carcinoma who are able to provide informed consent 2. Negative serum pregnancy test in female patients of childbearing potential at screening and consent to practise double-barrier contraception until a minimum of 42 days after 89Zr-TLX250 administration. 3. Histologically diagnosed with urothelial carcinoma or bladder cancer (or upper tract urothelial carcinoma diagnosed based on standard imaging and malignant urine cytology or direct visualisation on ureteroscopy) or known metastatic urothelial carcinoma or bladder cancer (based on previous imaging and /or histopathology)
Exclusion criteria
1. Active malignancy other than urothelial carcinoma or bladder cancer 2. Administration of a radioisotope within 10 physical half-lives prior to study enrolment. 3. Administration of chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to planned administration of 89Zr-TLX250 or continuing adverse effects from such therapy 4. Planned antineoplastic therapies for the period between administration of 89Zr-TLX250 and imaging 5. Serious non-malignant disease that may interfere with the objectives of the study 6. Renal insufficiency with glomerular filtration rate less than or equal to 45 mL/min/1.73m2 7. Pregnancy or lactation 8. Exposure to murine or chimeric antibodies within the last 5 years 9. Known hypersensitivity or human anti-chimeric antibodies against girentuximab 10. Exposure to any experimental diagnostic or therapeutic drug 30 days prior to the date of planned administration of 89Zr-TLX250 11. Contraindications to FDG PET/CT
Outcome results
None listed