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

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.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer
• Intervention / Treatment: Drug: 89Zr-TLX250

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• France
  • Saint-Herblain, France, 44805
    • Institut de Cancérologie de l'Ouest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• 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.

Exclusion Criteria:

• 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
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 89Zr-TLX250; 89Zr-TLX250 (89Zr-girentuximab) PET/CT performed for all aptients	Drug: 89Zr-TLX250; 89Zr-TLX250 (89Zr-girentuximab) PET/CT performed for all aptients; Other Names: [89Zr]Zr-girentuximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	3 days
Radiation Protection Management	Radiation exposure of 3 staff membres (extremities and Whole body: µSv). A value greater than 4mSv is considered abnormal.	3 days
Radiation Protection Management	Radiopharmaceutical management from intravesical instillation to elimination (surfasic contamination measured in counts/second).	1 day

Collaborators and Investigators

• Sponsor: Institut Cancerologie de l'Ouest
• Collaborators: ATONCO
• Investigators: Study Chair: Caroline ROUSSEAU, MD, PhD, Institut de Cancerologie de l'Ousest - ICO

Publications and helpful links

Helpful Links

• PubMed

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Actual): August 24, 2022
• Study Completion (Actual): September 26, 2022

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: pilot study; carbonic anhydrase IX (CAIX); Non-muscle-invasive bladder cancer (NMIBC); 89Zr-Girentuximab PET; 89Zr-TLX250 PET
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Urologic Neoplasms; Carcinoma; Urinary Bladder Diseases; Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms
• Other Study ID Numbers: ICO-2021-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No