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CompletedNCT04758780OPALESCENCEUpdated Jul 20, 2026Results posted

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

A Phase 2 interventional study of 89Zr-TLX250 in Triple Negative Breast Cancer, sponsored by Institut Cancerologie de l'Ouest. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.

Sponsored by Institut Cancerologie de l'Ouest · Phase 2, Interventional, and Diagnostic

Phase
Phase 2
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Triple Negative Breast Cancer

Keywords

  • carbonic anhydrase IX (CAIX)
  • 89Zr- girentuximab
  • 89Zr-TLX250 PET/CT
  • Metastatic Triple Negative Breast Cancer (TNBC)
03

In context

Triple Negative Breast Neoplasms

1,140 studies on the registry are indexed under Triple Negative Breast Neoplasms; 443 are open to participants now.

This study's enrollment of 12 is below the median of 61 across 982 interventional studies indexed under Triple Negative Breast Neoplasms.

Browse Triple Negative Breast Neoplasms studies →

Lead sponsor

Institut Cancerologie de l'Ouest is the lead sponsor of 105 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    89Zr-TLX250 PET/CT

    89Zr-TLX250 PET/CT

    Drug: 89Zr-TLX250

Interventions

  • Drug89Zr-TLX250

    89Zr-TLX250 PET/CT

    Also known as: 89Zr-girentuximab

06

What researchers measure

Primary outcomes

  1. 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

  2. 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 18FDG PET/CT. The detection performance of 89Zr-TLX250 PET/CT and 18FDG PET/CT for identifying brain lesions has been compared.

    Time frame: 5 days

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

07

Results

Posted Dec 30, 2025

Participant flow

Participant flow — Overall Study
Milestone89Zr-TLX250 PET/CT
Started12
Completed12
Not completed0

Outcome measures

PrimaryNumber 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
Reported as:
Number · lesions
Number of Total Lesions Detected on 89Zr-TLX250 PET/CT Versus 18FDG PET/CT
lesionsNumber of Total Lesions Detected on 89Zr-TLX250 PET/CT Versus 18FDG PET/CT
18FDG PET/CT264
89Zr-TLX250 PET/CT231
PrimaryNumber 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 18FDG PET/CT. The detection performance of 89Zr-TLX250 PET/CT and 18FDG PET/CT for identifying brain lesions has been compared.

Time frame:
5 days
Reported as:
Count of units · lesions
Number of Brain Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
lesionsNumber of Brain Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
89Zr-TLX250 PET/CT3
18FDG PET/CT1
SecondaryTumor 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
Reported as:
Median · cm3
Tumor Burden Volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT
cm3Tumor Burden Volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT
89Zr-TLX250 PET/CT D341.01 (16.71 to 138.68)
89Zr-TLX250 PET/CT D537.42 (24.70 to 173.75)
18FDG PET/CT D341.21 (13.42 to 184.16)
18FDG PET/CT D551.79 (29.17 to 103.26)
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Patient With Concordance Between the 89Zr-TLX250 PET/CT Uptake and CAIX Histological Expression
ParticipantsNumber of Patients With Concordance Between the 89Zr-TLX250 PET and CAIX Histological ExpressionNumber of Patients With no Concordance Between the 89Zr-TLX250 PET and CAIX Histological Expression
Number of Patient With Concordance Between the 89Zr-TLX250 PET/CT Uptake and CAIX Histological Expression75
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events Related to 89Zr-TLX250
ParticipantsNumber of Participants With Adverse Events Related to 89Zr-TLX250
Number of Participants With Adverse Events Related to 89Zr-TLX2500
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Serious Adverse Events Related or Not to 89Zr-TLX250
ParticipantsNumber of Participants With Serious Adverse Events Related or Not to 89Zr-TLX250
Number of Participants With Serious Adverse Events Related or Not to 89Zr-TLX2500
PrimaryNumber 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
Reported as:
Count of units · lesions
Number of Breast Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
lesionsNumber of Breast Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
89Zr-TLX250 PET/CT25
18FDG PET/CT23
PrimaryNumber 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
Reported as:
Count of units · lesions
Number of Bone Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
lesionsNumber of Bone Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
89Zr-TLX250 PET/CT102
18FDG PET/CT111
PrimaryNumber 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
Reported as:
Count of units · lesions
Number of Lymph Nodes Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
lesionsNumber of Lymph Nodes Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
89Zr-TLX250 PET/CT65
18FDG PET/CT74
PrimaryNumber 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
Reported as:
Count of units · lesions
Number of Lung Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
lesionsNumber of Lung Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
89Zr-TLX250 PET/CT17
18FDG PET/CT27
PrimaryNumber 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
Reported as:
Count of units · lesions
Number of Liver Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
lesionsNumber of Liver Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
89Zr-TLX250 PET/CT12
18FDG PET/CT19

Adverse events

Collected over Adverse events were evaluated during 30 days after [89Zr]Zr-girentuximab administration. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
89Zr-TLX250 PET/CT0/12 (0%)0/12 (0%)0/12 (0%)

Baseline characteristics

Metastatic triple negative breast cancer participants. Most patients received multiple treatments, with up to 4 treatments in combination (neoadjuvant and adjuvant chemotherapy, surgery and local radiotherapy). Of the 4 patients with immediate metastatic disease, 3 were enrolled without prior treatment, while the fourth received first-line targeted therapy.

Age, Categorical
Age, Categorical(Participants)89Zr-TLX250 PET/CT
<=18 years0
Between 18 and 65 years6
>=65 years6
Age, Continuous
Age, Continuous(years)89Zr-TLX250 PET/CT
Median68 (30 to 82)
Sex: Female, Male
Sex: Female, Male(Participants)89Zr-TLX250 PET/CT
Female12
Male0
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)89Zr-TLX250 PET/CT
Region of Enrollment
Region of Enrollment(participants)89Zr-TLX250 PET/CT
France12
08

Study locations

1 site
  • ICO René Gauducheau
    Saint-Herblain, 44805, France
09

References and documents

Publications

  • Rousseau C, Heyman MF, Ferrer L, Rauscher A, Morel A, Rusu D, Frenel JS, Taupin M, Vilcot L, Allam N, Robert M, Campone M, Campion L, Kraeber-Bodere F. Prospective pilot study with [89Zr]Zr-girentuximab PET/CT: CA-IX imaging in metastatic triple negative breast cancer (OPALESCENCE). Eur J Nucl Med Mol Imaging. 2026 Mar;53(4):2403-2413. doi: 10.1007/s00259-025-07619-y. Epub 2025 Nov 1. PubMed 41174094 ↗

Study documents

  • Protocol and statistical analysis plan · Jun 21, 2022

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04758780
Lead sponsor
Institut Cancerologie de l'Ouest
Collaborators
Tarix Pharmaceuticals, SIRIC ILIAD
Responsible party
Sponsor
First posted
Feb 17, 2021
Start date
Sep 21, 2021
Primary completion
Mar 31, 2023
Completion
Sep 13, 2023
Results posted
Dec 30, 2025
Last update
Jul 20, 2026

Study contacts

Caroline ROUSSEAU, MD
study chair · Institut de Cancerologie de l'Ousest - ICO

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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