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Imaging Performance Assessment of 89Zi-girentuximab (89Zr-TLX250) PET in Metastatic Triple Negative Breast Cancer

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04758780
Acronym
OPALESCENCE
Enrollment
12
Registered
2021-02-17
Start date
2021-09-21
Completion date
2023-09-13
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Triple Negative Breast Cancer

Keywords

carbonic anhydrase IX (CAIX), 89Zr- girentuximab, 89Zr-TLX250 PET/CT, Metastatic Triple Negative Breast Cancer (TNBC)

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.

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.

Interventions

DRUG89Zr-TLX250

89Zr-TLX250 PET/CT

Sponsors

Institut Cancerologie de l'Ouest
Lead SponsorOTHER
Tarix Pharmaceuticals
CollaboratorINDUSTRY
SIRIC ILIAD
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Monocentric, open prospective study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Total Lesions Detected on 89Zr-TLX250 PET/CT Versus 18FDG PET/CT5 daysThe number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CT is reported to assess the concordance for tumor lesion detection using 89Zr-TLX250 PET/CT and 18FDG) PET/CT
Number of Brain Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT5 daysNumber of brain lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and 18FDG PET/CT. The detection performance of 89Zr-TLX250 PET/CT and 18FDG PET/CT for identifying brain lesions has been compared.
Number of Breast Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT5 daysNumber of breast lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT
Number of Bone Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT5 daysNumber of bone lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT
Number of Lymph Nodes Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT5 daysNumber of lymph nodes lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT
Number of Lung Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT5 daysNumber of lung lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT
Number of Liver Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT5 daysNumber of liver lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT

Secondary

MeasureTime frameDescription
Tumor Burden Volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT5 daysTotal tumor burden (whole body) detected on 89Zr-TLX250 PET/CT scan compared to that defined on 18FDG PET/CT used as the reference performed at day 3 (D3) and at day 5 (D5)
Number of Patient With Concordance Between the 89Zr-TLX250 PET/CT Uptake and CAIX Histological Expression5 daysNumber of patients with a concordance between the 89Zr-TLX250 PET/CT uptake and CAIX histological expression considered as positive or negative
Number of Participants With Adverse Events Related to 89Zr-TLX25030 daysAll Adverse Events related to 89Zr-TLX250 are reported and assessed using CTCAE v5.0 scale
Number of Participants With Serious Adverse Events Related or Not to 89Zr-TLX25030 daysAll Serious Adverse Events are collected between the 89Zr-TLX250 administration and 30 days after. They assessed using CTCAE v5.0 scale

Countries

France

Contacts

STUDY_CHAIRCaroline ROUSSEAU, MD

Institut de Cancerologie de l'Ousest - ICO

Participant flow

Participants by arm

ArmCount
89Zr-TLX250 PET/CT
Pretherapeutic 89Zr-TLX250 PET/CT 89Zr-TLX250 PET/CT: Pretherapeutic 89Zr-TLX250 PET/CT
12
Total12

Baseline characteristics

Characteristic89Zr-TLX250 PET/CT
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
6 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
Age, Continuous68 years
Region of Enrollment
France
12 participants
Sex: Female, Male
Female
12 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 12
other
Total, other adverse events
0 / 12
serious
Total, serious adverse events
0 / 12

Outcome results

Primary

Number of Bone Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT

Number of bone lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT

Time frame: 5 days

ArmMeasureGroupValue (COUNT_OF_UNITS)
Number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CTNumber of Bone Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT89Zr-TLX250 PET/CT102 lesions
Number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CTNumber of Bone Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT18FDG PET/CT111 lesions
Primary

Number of Brain Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT

Number of brain lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT

Time frame: 5 days

ArmMeasureGroupValue (COUNT_OF_UNITS)
Number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CTNumber of Brain Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT89Zr-TLX250 PET/CT3 lesions
Number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CTNumber of Brain Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT18FDG PET/CT1 lesions
Primary

Number of Breast Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT

Number of breast lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT

Time frame: 5 days

ArmMeasureGroupValue (COUNT_OF_UNITS)
Number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CTNumber of Breast Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT89Zr-TLX250 PET/CT25 lesions
Number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CTNumber of Breast Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT18FDG PET/CT23 lesions
Primary

Number of Liver Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT

Number of liver lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT

Time frame: 5 days

ArmMeasureGroupValue (COUNT_OF_UNITS)
Number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CTNumber of Liver Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT89Zr-TLX250 PET/CT12 lesions
Number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CTNumber of Liver Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT18FDG PET/CT19 lesions
Primary

Number of Lung Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT

Number of lung lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT

Time frame: 5 days

ArmMeasureGroupValue (COUNT_OF_UNITS)
Number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CTNumber of Lung Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT89Zr-TLX250 PET/CT17 lesions
Number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CTNumber of Lung Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT18FDG PET/CT27 lesions
Primary

Number of Lymph Nodes Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT

Number of lymph nodes lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT

Time frame: 5 days

ArmMeasureGroupValue (COUNT_OF_UNITS)
Number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CTNumber of Lymph Nodes Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT89Zr-TLX250 PET/CT65 lesions
Number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CTNumber of Lymph Nodes Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT18FDG PET/CT74 lesions
Primary

Number of Total Lesions Detected on 89Zr-TLX250 PET/CT Versus 18FDG PET/CT

The number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CT is reported to assess the concordance for tumor lesion detection using 89Zr-TLX250 PET/CT and 18FDG) PET/CT

Time frame: 5 days

ArmMeasureGroupValue (NUMBER)
Number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CTNumber of Total Lesions Detected on 89Zr-TLX250 PET/CT Versus 18FDG PET/CT18FDG PET/CT264 lesions
Number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CTNumber of Total Lesions Detected on 89Zr-TLX250 PET/CT Versus 18FDG PET/CT89Zr-TLX250 PET/CT231 lesions
Secondary

Number of Participants With Adverse Events Related to 89Zr-TLX250

All Adverse Events related to 89Zr-TLX250 are reported and assessed using CTCAE v5.0 scale

Time frame: 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CTNumber of Participants With Adverse Events Related to 89Zr-TLX2500 Participants
Secondary

Number of Participants With Serious Adverse Events Related or Not to 89Zr-TLX250

All Serious Adverse Events are collected between the 89Zr-TLX250 administration and 30 days after. They assessed using CTCAE v5.0 scale

Time frame: 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CTNumber of Participants With Serious Adverse Events Related or Not to 89Zr-TLX2500 Participants
Secondary

Number of Patient With Concordance Between the 89Zr-TLX250 PET/CT Uptake and CAIX Histological Expression

Number of patients with a concordance between the 89Zr-TLX250 PET/CT uptake and CAIX histological expression considered as positive or negative

Time frame: 5 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CTNumber of Patient With Concordance Between the 89Zr-TLX250 PET/CT Uptake and CAIX Histological Expression7 Participants
Number of patients with no concordance between the 89Zr-TLX250 PET and CAIX histological expressionNumber of Patient With Concordance Between the 89Zr-TLX250 PET/CT Uptake and CAIX Histological Expression5 Participants
Secondary

Tumor Burden Volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT

Total tumor burden (whole body) detected on 89Zr-TLX250 PET/CT scan compared to that defined on 18FDG PET/CT used as the reference performed at day 3 (D3) and at day 5 (D5)

Time frame: 5 days

ArmMeasureGroupValue (MEDIAN)
Number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CTTumor Burden Volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT89Zr-TLX250 PET/CT D341.01 cm3
Number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CTTumor Burden Volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT89Zr-TLX250 PET/CT D537.42 cm3
Number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CTTumor Burden Volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT18FDG PET/CT D341.21 cm3
Number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CTTumor Burden Volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT18FDG PET/CT D551.79 cm3

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026