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Imaging Performance Assessment of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET-CT in Metastatic Triple Negative Breast Cancer Patients (OPALESCENCE)

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ClinicalTrials.gov Identifier: NCT04758780
Recruitment Status : Recruiting
First Posted : February 17, 2021
Last Update Posted : October 19, 2021
Sponsor:
Collaborators:
Telix Pharmaceutical
SIRIC ILIAD
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 tracer for the imaging of metastatic triple negative breast cancer (TNBC) patients.

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Drug: 89Zr-TLX250 PET/CT Phase 2

Detailed 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 tracer for the imaging of metastatic triple negative breast cancer (TNBC) patients.

TNBC patients are known to be rapidly progressive and have a poor prognosis. This poor prognosis is due to the lack of common breast cancer targets in TNBC. As TNBC expresses CAIX, this stuy will evaluate CAIX targeting by using a radiolabeled monoclonal antibody that recognizes carbonic anhydrase IX (CAIX) : 89Zr- girentuximab otherwise known as 89Zr-TLX250. Previous and ongoing studies have demonstrated the potential application of 89Zr-TLX250 as a new PET/CT imaging tracer for the detection of renal cancer.

After establishing the TNBC targeting properties of the 89Zr-TLX250 PET/CT imaging tracer, it should be interesting to develop a new targeted therapy using TLX250- radiolabeled with a therapeutic radionuclide such as 177Lutétium.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 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: Prospective Phase II Pilot Study, Assessing Imaging Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET-CT (Positron Emission Tomography/Computerized Tomography) in Metastatic Triple Negative Breast Cancer Patients
Actual Study Start Date : September 21, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Zirconium

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. Assess the concordance for tumor lesion detection using 89Zr-TLX250 PET/CT versus a conventional 18FDG PET/CT scan [ Time Frame: 35 days ]
    Assess the concordance for tumor lesion detection using 89Zr-TLX250 PET/CT scan : Positron Emission Tomography/Computerized Tomography scan versus a conventional 18 Fluorodésoxyglucose (18FDG) PET/CT scan where comparison will be made on a per lesion analysis basis


Secondary Outcome Measures :
  1. determine the percent of total tumor burden (whole body) detected on 89Zr-TLX250 PET/CT scan compared to that defined on 18FDG PET/CT used as the reference [ Time Frame: 35 days ]
    Percent of positive CA IX metastatic tumor burden compared to total metastatic tumor burden by 18FDG (ratio "Number of positive 89Zr-TLX250 lesions / Number of positive FDG lesions

  2. Assess the correlation between the Standardized Uptake Values (SUV) of 89Zr-TLX250 and CAIX histological expression if a biopsy is done [ Time Frame: 35 days ]
    If a metastasis biopsy is conducted, assessment of the correlation between the normalized uptake values (SUV) of 89Zr-TLX250 positive lesions and CAIX histological expression will be done by comparing the 89Zr-TLX250 semi-quantitative data with the immunohistochemical results (IHC) of biopsied metastases

  3. Vital signs measurment after 89Zr-TLX250 injection [ Time Frame: 2 Hours ]
    Vital signs will be measured within 2 hours after 89Zr-TLX250 injection

  4. Assess the generation of Human Anti-Chimeric Antibodies (HACA) in response to the girentuximab [ Time Frame: 3 months ]
    A blood sample will be drawn before 89Zr-TLX250 injection and 3 months after in order to evaluate the presence of Human anti-chimeric antibody (HACA) in sera of patients. This will be tested quantitatively and qualitatively using validated ELISAs HACA

  5. Number of participants with adverse events and Serious Adverse Events related to 89Zr-TLX250 as assessed by CTCAE v5.0 [ Time Frame: 30 days ]
    All Adverse Events and Serious Adverse Events due to 89Zr-TLX250 will be reported

  6. Number of participants with Serious Adverse Events related to 89Zr-TLX250 as assessed by CTCAE v5.0 [ Time Frame: 30 days ]
    All Serious Adverse Events due to 89Zr-TLX250 will be reported



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
Criteria

Inclusion Criteria:

  • Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
  • Female or male, Age ≥ 18 years at time of study entry.
  • Primitive triple negative breast cancer proven histologically, defined according to the following criteria:

    • Estrogen receptors <10%.
    • And progesterone receptors <10%.
    • And Human Epidermal Growth factor Receptor 2 (HER2) not amplified or not overexpressed.
  • Breast Cancer (BC) recurrence documented by conventional imaging and/or FDG PET/CT with at least one measurable metastatic lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) and/or PET Response Criteria In Solid Tumors (PERCIST).
  • Consent to use a contraception method for at least 30 days after administration of 89Zr-TLX250.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
  • Life expectancy at least 6 months.
  • Patient has valid health insurance.
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Exclusion Criteria:

  • History of another primary malignancy except for basal cell carcinoma within the last 5 years.
  • Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the planned administration of 89Zr-TLX250 or continuing adverse effects (> grade 1) from such therapy (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0).
  • Planned antineoplastic therapies (for the period between IV administration of 89Zr-TLX250 and imaging).
  • Exposure to murine or chimeric antibodies within the last 5 years.
  • Previous administration of any radionuclide within 10 half-lives of the same.
  • Impossibility to hold lying motionless at least 1 hour, or known claustrophobia.
  • Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic), that may interfere with the objectives of the study or with the safety or compliance of the subject, as judged by the investigator.
  • Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
  • Pregnant or likely to be pregnant or nursing patient.
  • Known hypersensitivity to girentuximab or desferoxamine.
  • Renal insufficiency with Glomerular Filtration Rate : GFR ≤ 45 mL/min/ 1.73 m².
  • Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian.
  • Disorder precluding understanding of trial information or informed consent.

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): NCT04758780


Contacts
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Contact: Caroline ROUSSEAU, MD + 33 240679931 caroline.rousseau@ico.unicancer.fr
Contact: Nadia ALLAM, PhD +33 240679826 nadia.allam@ico.unicancer.fr

Locations
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France
ICO René Gauducheau Recruiting
Saint-Herblain, France, 44805
Contact: ROUSSEAU Caroline, MD    +33 2 40 67 99 00    caroline.rousseau@ico.unicancer.fr   
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
Telix Pharmaceutical
SIRIC ILIAD
Investigators
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Study Chair: Caroline ROUSSEAU, MD Institut de Cancerologie de l'Ousest - ICO
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Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT04758780    
Other Study ID Numbers: ICO-2020-25
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: October 19, 2021
Last Verified: October 2021

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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:
89Zr-TLX250 (89Zirconium-TLX250)
Positron Emission Tomography/Computerized Tomography (PET/CT) scan
carbonic anhydrase IX (CAIX)
89Zr- girentuximab (89Zirconium-girentuximab)
89Zr-TLX250 PET/CT
Metastatic Triple Negative Breast Cancer (TNBC)
Human Anti-Chimeric Antibodies (HACA)
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases