An Early Phase 1 interventional study of 89Zr-TLX250 in Bladder Cancer, sponsored by Institut Cancerologie de l'Ouest. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by Institut Cancerologie de l'Ouest · Early Phase 1, Interventional, and Diagnostic
The purpose of this study is to evaluate the use of 89Zr-labeled girentuximab (89Zr-TLX250) as a novel, carbonic anhydrase IX (CAIX) targeted PET/CT radiopharmaceutical for the imaging of Non-muscle-invasive bladder cancer (NMIBC) patients.
There is a real need for treatment of NMIBC. Currently, treatment options include Bacillus Calmette-Guerin (BCG) intravesical immunotherapy and mitomycin C chemotherapy. These therapies are efficient for some time but relapses repeat them at more and more close intervals and finally patients are refractory to them and require a radical cystectomy.
CAIX is expressed in 70% to 90% of bladder cancers but not in normal urothelial tissue. CAIX is expressed on the membrane of Non-Muscle-Invasive Bladder Cancer cells.
Girentuximab, an anti-CAIX antibody could be a promising target in NMIBC. PET/CT with Girentuximab labelled with 89Zirconium will be used for diagnosis purpose. 89Zr-Girentuximab will be administered by intravesical instillation.
In this study, patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) will be enrolled in this study after confirmation of their eligibility.
A single intravesical administration of 89Zr-Girentuximab will be performed at day 0.
Multiple PET/CT imaging sessions will be performed on day 0, day 1 and day 2 in order to evaluate the bladder and the whole body 89Zr girentuximab uptake.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's enrollment of 6 is below the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Institut Cancerologie de l'Ouest is the lead sponsor of 105 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
89Zr-TLX250 (89Zr-girentuximab) PET/CT performed for all aptients
Drug: 89Zr-TLX250
89Zr-TLX250 (89Zr-girentuximab) PET/CT performed for all aptients
Also known as: [89Zr]Zr-girentuximab
Number of Participants With Uptake Spot in 89Zr-girentuximab PET/CT Images
The presence or absence of uptake spot in bladder wall of 89Zr-girentuximab bladder and whole body PET/CT Images.
Time frame: 3 days
Number of Patients With Positive and Negative 89Zr-girentuximab Blood Dosing
89Zr-girentuximab activity dosing in blood is measured. The number of patients with Positive and negative 89Zr-girentuximab Blood dosing is evaluated.
Time frame: 2 days
Number of Participants With Serious Adverse Events
Serious adverse events, related or not to 89Zr-girentuximab, are assessed up to Day 30 after 89Zr-girentuximab administration, using CTC-AE scale version 5.0
Time frame: 30 days
Number of Patients With Positive and Negative CA-IX Expression in Tumor Cells
The expression of CAIX is by immunohistochemistry in tumor sample from TransUrethral Resection of Bladder Tumor (TURBT) or cystectomy
Time frame: 3 months
Number of Participants With Adverse Events Related to 89Zr-girentuximab
Adverse events related to 89Zr-girentuximab are assessed up to Day 3 After 89Zr-girentuximab Administration, using CTC-AE scale version 5.0
Time frame: 3 days
Radiation Protection Management
Radiation exposure of 3 staff membres (extremities and Whole body: µSv). A value greater than 4mSv is considered abnormal.
Time frame: 3 days
Radiation Protection Management
Radiopharmaceutical management from intravesical instillation to elimination (surfasic contamination measured in counts/second).
Time frame: 1 day
Study start date First patient was enrolled: 15 DEC 2021 End of trial date (last visit of last patient): 26 SEP 2022
| Milestone | 89Zr-TLX250 PET/CT |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
The presence or absence of uptake spot in bladder wall of 89Zr-girentuximab bladder and whole body PET/CT Images.
| Participants | 89Zr-TLX250 (89Zr-girentuximab) PET/CT |
|---|---|
| Uptake spot in bladder wall with early recurrence | 1 |
| Uptake spot in bladder wall with post-TURB inflammatory scarring reaction | 2 |
| No uptake spot in bladder wall | 3 |
89Zr-girentuximab activity dosing in blood is measured. The number of patients with Positive and negative 89Zr-girentuximab Blood dosing is evaluated.
| Participants | 89Zr-TLX250 (89Zr-girentuximab) PET/CT |
|---|---|
| Positive 89Zr-girentuximab Blood dosing | 1 |
| Negative 89Zr-girentuximab Blood dosing | 5 |
Serious adverse events, related or not to 89Zr-girentuximab, are assessed up to Day 30 after 89Zr-girentuximab administration, using CTC-AE scale version 5.0
| Participants | 89Zr-TLX250 (89Zr-girentuximab) PET/CT |
|---|---|
| Urinary retention grade 2 not related to 89Zr-TLX250 (89Zr-girentuximab) PET/CT | 1 |
| Haemorrhage grade 3 not related to 89Zr-TLX250 (89Zr-girentuximab) PET/CT | 1 |
| No SAE | 4 |
The expression of CAIX is by immunohistochemistry in tumor sample from TransUrethral Resection of Bladder Tumor (TURBT) or cystectomy
| Participants | 89Zr-TLX250 (89Zr-girentuximab) PET/CT |
|---|---|
| Positive CA-IX expression in tumor cells | 5 |
| Negative CA-IX expression in tumor cells | 1 |
Adverse events related to 89Zr-girentuximab are assessed up to Day 3 After 89Zr-girentuximab Administration, using CTC-AE scale version 5.0
| Participants | 89Zr-TLX250 (89Zr-girentuximab) PET/CT |
|---|---|
| Urethral bleeding grade 1 not related to 89Zr-TLX250 (89Zr-girentuximab) PET/CT | 1 |
| No adverse events | 5 |
Radiation exposure of 3 staff membres (extremities and Whole body: µSv). A value greater than 4mSv is considered abnormal.
| µSv | 89Zr-TLX250 (89Zr-girentuximab) PET/CT |
|---|---|
| Whole body radiation exposure of staff | 5.5 (1 to 10) |
| Extremities radiation exposure of staff | 5 (0 to 10) |
Radiopharmaceutical management from intravesical instillation to elimination (surfasic contamination measured in counts/second).
| counts per second | 89Zr-TLX250 (89Zr-girentuximab) PET/CT |
|---|---|
| Radiation Protection Management | 115 (50 to 180) |
Collected over From the date of administration of 89Zr- Girentuximab until 30 days after administration. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 89Zr-TLX250 | 0/6 (0%) | 2/6 (33.3%) | 1/6 (16.7%) |
| Event | 89Zr-TLX250 |
|---|---|
| Urinary retentionRenal and urinary disorders | 1/6 |
| Bladder bleedingRenal and urinary disorders | 1/6 |
| Event | 89Zr-TLX250 |
|---|---|
| Urethral bleedingRenal and urinary disorders | 1/6 |
| Age, Categorical(Participants) | 89Zr-TLX250 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 6 |
| Sex: Female, Male(Participants) | 89Zr-TLX250 |
|---|---|
| Female | 2 |
| Male | 4 |
| Race and Ethnicity Not Collected(Participants) | 89Zr-TLX250 |
|---|
| Region of Enrollment(Participants) | 89Zr-TLX250 |
|---|---|
| France | 6 |
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Institut Cancerologie de l'Ouest