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Assessment of safEty, Tolerability, Radiation Dosimetry, and Imaging Properties of 89Zr-labeled giRenTuximab (89Zr-Girentuximab) in patIents With Non-musclE-iNvasive Bladder CancEr (NMIBC) (PERTINENCE)

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ClinicalTrials.gov Identifier: NCT04897763
Recruitment Status : Completed
First Posted : May 24, 2021
Last Update Posted : February 21, 2023
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest

Brief 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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: 89Zr-TLX250 PET/CT Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Monocentric, open prospective study
Masking: None (Open Label)
Primary Purpose: Diagnostic
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)
Actual Study Start Date : October 1, 2021
Actual Primary Completion Date : August 24, 2022
Actual Study Completion Date : September 26, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 89Zr-TLX250 PET/CT
Pretherapeutic 89Zr-TLX250 PET/CT
Drug: 89Zr-TLX250 PET/CT
Pretherapeutic 89Zr-TLX250 PET/CT

Primary Outcome Measures :
  1. PET/CT imaging 89Zr-girentuximab biodistribution assessment [ Time Frame: 3 days ]
    Standardized Uptake Values (SUVs) of bladder and whole body uptake will be evaluated by PET/CT imaging at T0, T0+2 hours, T0+20 hours and T0+44 hours

  2. 89Zr-girentuximab Blood dosing [ Time Frame: 2 days ]
    89Zr-girentuximab activity dosing in blood will be measured (Becquerel/ml : Bq/ml) at T0+20 hours

Secondary Outcome Measures :
  1. Assess the toxicity of 89Zr-girentuximab administered by intravesical instillation [ Time Frame: 30 days ]
    Number of adverse events due to intravesical administration of 89Zr-Girentuximab up to Day 30 after 89Zr-girentuximab administration. Adverse events will be assessed by using CTC-AE scale version 5.0

  2. Radiation protection management [ Time Frame: 3 days ]
    Radiation exposure of staff (extremities, lens and Whole body: µSv)

  3. Radiation protection management [ Time Frame: 1 day ]
    Radiopharmaceutical management from intravesical instillation to elimination (surfasic contamination: counts/cm2 or Bq/cm2)

  4. Assess the degree of CAIX expression by immunohistochemistry of the tumor [ Time Frame: 3 months ]
    The expression of CAIX will be assessed by immunohistochemistry in tumor sample from TransUrethral Resection of Bladder Tumor (TURBT) or cystectomy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04897763

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Institut de cancerologie de l'Ouest
Saint Herblain, France, 44805
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
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Study Chair: Caroline ROUSSEAU, MD, PhD Institut de Cancerologie de l'Ousest - ICO
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Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT04897763    
Other Study ID Numbers: ICO-2021-03
First Posted: May 24, 2021    Key Record Dates
Last Update Posted: February 21, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Cancerologie de l'Ouest:
Non-muscle-invasive bladder cancer (NMIBC) patients
89Zr-Girentuximab ((89Zirconium-Girentuximab) PET/CT
Safety assessment
pilot study
feasibility study
89Zr-TLX250 (89Zirconium-TLX250) PET/CT
Positron Emission Tomography/Computerized Tomography (PET/CT) scan
carbonic anhydrase IX (CAIX)
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases