NCT04897763: PERTINENCE

Assessment of Safety, Tolerability, Radiation Dosimetry, Imaging Properties of 89Zr-girentuximab in Patients With NMIBC

Completed EARLY_PHASE1 Results posted Last updated 7 January 2026

What this trial tests

EARLY_PHASE1 trial testing 89Zr-TLX250 in Bladder Cancer in 6 participants. Completed in 26 September 2022.

Timeline

15 December 2021

Primary endpoint
24 August 2022

26 September 2022

Quick facts

Lead sponsor	Institut Cancerologie de l'Ouest
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	6
Start date	15 December 2021
Primary completion	24 August 2022
Estimated completion	26 September 2022
Sites	1 location across France

Drugs / interventions tested

• 89Zr-TLX250 — full drug profile →

Conditions studied

• Bladder Cancer — all drugs for Bladder Cancer →

Sponsor

Institut Cancerologie de l'Ouest — full company profile →

Who can join

18 and older, any sex, with Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Uptake Spot in 89Zr-girentuximab PET/CT Images Primary · 3 days

The presence or absence of uptake spot in bladder wall of 89Zr-girentuximab bladder and whole body PET/CT Images.

Group	Value	95% CI
89Zr-TLX250 (89Zr-girentuximab) PET/CT	1
89Zr-TLX250 (89Zr-girentuximab) PET/CT	2
89Zr-TLX250 (89Zr-girentuximab) PET/CT	3

Number of Patients With Positive and Negative 89Zr-girentuximab Blood Dosing Primary · 2 days

89Zr-girentuximab activity dosing in blood is measured. The number of patients with Positive and negative 89Zr-girentuximab Blood dosing is evaluated.

Group	Value	95% CI
89Zr-TLX250 (89Zr-girentuximab) PET/CT	1
89Zr-TLX250 (89Zr-girentuximab) PET/CT	5

Number of Participants With Serious Adverse Events Secondary · 30 days

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

Group	Value	95% CI
89Zr-TLX250 (89Zr-girentuximab) PET/CT	1
89Zr-TLX250 (89Zr-girentuximab) PET/CT	1
89Zr-TLX250 (89Zr-girentuximab) PET/CT	4

Number of Patients With Positive and Negative CA-IX Expression in Tumor Cells Secondary · 3 months

The expression of CAIX is by immunohistochemistry in tumor sample from TransUrethral Resection of Bladder Tumor (TURBT) or cystectomy

Group	Value	95% CI
89Zr-TLX250 (89Zr-girentuximab) PET/CT	5
89Zr-TLX250 (89Zr-girentuximab) PET/CT	1

Number of Participants With Adverse Events Related to 89Zr-girentuximab Secondary · 3 days

Adverse events related to 89Zr-girentuximab are assessed up to Day 3 After 89Zr-girentuximab Administration, using CTC-AE scale version 5.0

Group	Value	95% CI
89Zr-TLX250 (89Zr-girentuximab) PET/CT	1
89Zr-TLX250 (89Zr-girentuximab) PET/CT	5

Radiation Protection Management Secondary · 3 days

Radiation exposure of 3 staff membres (extremities and Whole body: µSv). A value greater than 4mSv is considered abnormal.

Whole body radiation exposure of staff

Group	Value	95% CI
89Zr-TLX250 (89Zr-girentuximab) PET/CT	5.5	1 – 10

Extremities radiation exposure of staff

Group	Value	95% CI
89Zr-TLX250 (89Zr-girentuximab) PET/CT	5	0 – 10

Radiation Protection Management Secondary · 1 day

Radiopharmaceutical management from intravesical instillation to elimination (surfasic contamination measured in counts/second).

Group	Value	95% CI
89Zr-TLX250 (89Zr-girentuximab) PET/CT	115	50 – 180

Adverse events — posted to ClinicalTrials.gov

Time frame: From the date of administration of 89Zr- Girentuximab until 30 days after administration. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

89Zr-TLX250

Serious: 2/6 (33%)

Deaths: 0/6

Serious adverse events (2 terms)

Reaction	System	89Zr-TLX250
Urinary retention	Renal and urinary disorders	—
Bladder bleeding	Renal and urinary disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	89Zr-TLX250
Urethral bleeding	Renal and urinary disorders	—

Most-reported serious reactions: Urinary retention, Bladder bleeding.

Data from ClinicalTrials.gov NCT04897763 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Radiolabeled Antibodies for Cancer Imaging and Therapy.
   Parakh S, Lee ST, Gan HK, Scott AM. · · 2022 · cited 78× · PMID 35326605 · DOI 10.3390/cancers14061454
2. Targeting carbonic anhydrase IX and XII isoforms with small molecule inhibitors and monoclonal antibodies.
   Kciuk M, Gielecińska A, Mujwar S, Mojzych M, et al · · 2022 · cited 65× · PMID 35506234 · DOI 10.1080/14756366.2022.2052868
3. Targeted Alpha-Particle Therapy: A Review of Current Trials.
   Jang A, Kendi AT, Johnson GB, Halfdanarson TR, et al · · 2023 · cited 59× · PMID 37511386 · DOI 10.3390/ijms241411626
4. Preclinical and Clinical Feasibility Studies as the First Step Before Forthcoming Intravesical Instillation of [<sup>211</sup>At]At-anti-CA-IX Antibody (ATO-101™) Study in Patients with Non-Muscle-Invasive Bladder Cancer Unresponsive to Standard of Care.
   Rousseau C, Baumgartner P, Heymann MF, Taupin M, et al · · 2025 · cited 2× · PMID 40227816 · DOI 10.3390/cancers17071190
5. The false myth of "iodine allergy" also in nuclear medicine.
   Gómez-Perales JL, García-Mendoza A. · · 2021 · cited 2× · PMID 34585268 · DOI 10.1007/s00259-021-05356-6