Bladder CancerEarly Phase 1PERTINENCENCT04897763
Assessment of Safety, Tolerability, Radiation Dosimetry, Imaging Properties of 89Zr-girentuximab in Patients With NMIBC
A Early Phase 1 study testing 89Zr-TLX250 in people with Bladder Cancer, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- 89Zr-TLX250
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2021to 26 Sep 2022
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Female or male, Age ≥ 18 years at time of study entry.
- Performance Status: 0 or 1.
- Clinical evidence of NMIBC based on cystoscopy and proven histologically of papillary tumors.
- Histologically-confirmed pTa Grade 3 or pT1 Grade 3 bladder cancer patients relapsing without muscle invasion.
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- Negative sterile Urine cytobacteriological testing at baseline (T0).
- Consent to use a contraception method for at least 30 days after administration of 89Zr-girentuximab.
- Patient has valid health insurance.
Who cannot join
- Patient with urinary incontinence.
- Known hypersensitivity to girentuximab.
- Exposure to any experimental diagnostic or therapeutic drug within 30 days prior the date of planned administration of 89Zr-girentuximab
- Exposure to any radiopharmaceutical within 30 days (corresponding to 10 half-lives of Zr-89) prior to the administration of 89Zr-girentuximab
- Patients suffering from a bladder cancer at stage pT2, pT3 or pT4
- Serious non-malignant disease that may interfere with the objectives of the study or with the safety or compliance of the patient; as judged by the investigator
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- Concomitant cancer in the past 5 years except cutaneous cancers (except melanoma) and in situ carcinoma
- Prior chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), immunotherapy within 21 days of 89Zr-girentuximab administration
- Patients with known human immunodeficiency viruses (HIV), Hepatitis B virus (HBV) and Hepatitis C Virus (HCV) infections,
- Pregnant or likely to be pregnant or nursing patient.
- Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
- Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Open-label, Feasibility Study to Assess safEty, Tolerability, Radiation Dosimetry, and Imaging Properties of 89Zr-labeled giRenTuximab (89Zr-Girentuximab) in patIents With Non-musclE-iNvasive Bladder CancEr (NMIBC)
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.
Read the detailed description
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.
- Conditions
- Bladder Cancer
- Being tested
- 89Zr-TLX250
- Keywords
- Non-muscle-invasive bladder cancer (NMIBC), 89Zr-Girentuximab PET, pilot study, 89Zr-TLX250 PET, carbonic anhydrase IX (CAIX)
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-TLX250Drug
Also called [89Zr]Zr-girentuximab
89Zr-TLX250 (89Zr-girentuximab) PET/CT performed for all aptients
| Study group | Role | What they receive |
|---|---|---|
| 89Zr-TLX250 | Experimental | 89Zr-TLX250 (89Zr-girentuximab) PET/CT performed for all aptients Receives: Drug: 89Zr-TLX250 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 days
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 3 days
Radiation Protection Management
Radiation exposure of 3 staff membres (extremities and Whole body: µSv). A value greater than 4mSv is considered abnormal.
Measured: 3 days
Radiation Protection Management
Radiopharmaceutical management from intravesical instillation to elimination (surfasic contamination measured in counts/second).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start15 Dec 2021
- Primary completion24 Aug 2022
- Study completion26 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Monocentric, open prospective study
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Collaborators
- ATONCO
- Responsible party
- Sponsor
- Investigators
- Caroline ROUSSEAU, MD, PhD, Study chair, Institut de Cancerologie de l'Ousest - ICO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897763
- Sponsor's protocol ID
- ICO-2021-03
- Acronym
- PERTINENCE
- Status last verified
- Sep 2025
- First submitted
- 17 May 2021
- Last updated
- 7 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Open-label, Feasibility Study to Assess safEty, Tolerability, Radiation Dosimetry, and Imaging Properties of 89Zr-labeled giRenTuximab (89Zr-Girentuximab) in patIents With Non-musclE-iNvasive Bladder CancEr (NMIBC)
- ClinicalTrials.gov ID
- NCT04897763
- Acronym / sponsor ID
- PERTINENCE / ICO-2021-03
- Conditions
- Bladder Cancer
- Keywords
- Non-muscle-invasive bladder cancer (NMIBC), 89Zr-Girentuximab PET, pilot study, 89Zr-TLX250 PET, carbonic anhydrase IX (CAIX)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Collaborators
- ATONCO
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 24 Aug 2022 (actual)
- Study completion
- 26 Sep 2022 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Posted 7 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monocentric, open prospective study
| Arm | Type | Receives |
|---|---|---|
| 89Zr-TLX250 | Experimental | Drug: 89Zr-TLX25089Zr-TLX250 (89Zr-girentuximab) PET/CT performed for all aptients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Female or male, Age ≥ 18 years at time of study entry.
- Performance Status: 0 or 1.
- Clinical evidence of NMIBC based on cystoscopy and proven histologically of papillary tumors.
Key exclusion criteria (12 listed)
- Patient with urinary incontinence.
- Known hypersensitivity to girentuximab.
- Exposure to any experimental diagnostic or therapeutic drug within 30 days prior the date of planned administration of 89Zr-girentuximab
- Exposure to any radiopharmaceutical within 30 days (corresponding to 10 half-lives of Zr-89) prior to the administration of 89Zr-girentuximab
- Patients suffering from a bladder cancer at stage pT2, pT3 or pT4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 89Zr-TLX250Also: [89Zr]Zr-girentuximab89Zr-TLX250 (89Zr-girentuximab) PET/CT performed for all aptients | Drug | 89Zr-TLX250 |
Primary outcome
Number of Participants With Uptake Spot in 89Zr-girentuximab PET/CT Images
Time frame: 3 days
The presence or absence of uptake spot in bladder wall of 89Zr-girentuximab bladder and whole body PET/CT Images.
Number of Patients With Positive and Negative 89Zr-girentuximab Blood Dosing
Time frame: 2 days
89Zr-girentuximab activity dosing in blood is measured. The number of patients with Positive and negative 89Zr-girentuximab Blood dosing is evaluated.
5 secondary outcomes
Number of Participants With Serious Adverse Events
Time frame: 30 days
Number of Patients With Positive and Negative CA-IX Expression in Tumor Cells
Time frame: 3 months
Number of Participants With Adverse Events Related to 89Zr-girentuximab
Time frame: 3 days
Radiation Protection Management
Time frame: 3 days
Radiation Protection Management
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- PubMedLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline ROUSSEAU, MD, PhD study chair
Institut de Cancerologie de l'Ousest - ICO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 89Zr-TLX250 in people with Bladder Cancer, run by Institut Cancerologie de l'Ouest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Uptake Spot in 89Zr-girentuximab PET/CT Images (time frame: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.