18 and older, any sex, with Triple Negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Total Lesions Detected on 89Zr-TLX250 PET/CT Versus 18FDG PET/CTPrimary· 5 days
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
18FDG PET/CT
Group
Value
95% CI
Number of Total Lesions Detected on 89Zr-TLX250 PET/CT Versus 18FDG PET/CT
264
89Zr-TLX250 PET/CT
Group
Value
95% CI
Number of Total Lesions Detected on 89Zr-TLX250 PET/CT Versus 18FDG PET/CT
231
Number of Brain Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CTPrimary· 5 days
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.
89Zr-TLX250 PET/CT
Group
Value
95% CI
Number of Brain Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
3
18FDG PET/CT
Group
Value
95% CI
Number of Brain Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
1
Tumor Burden Volume by 18FDG PET/CT and 89Zr-TLX250 PET/CTSecondary· 5 days
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)
89Zr-TLX250 PET/CT D3
Group
Value
95% CI
Tumor Burden Volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT
41.01
16.71 – 138.68
89Zr-TLX250 PET/CT D5
Group
Value
95% CI
Tumor Burden Volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT
37.42
24.70 – 173.75
18FDG PET/CT D3
Group
Value
95% CI
Tumor Burden Volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT
41.21
13.42 – 184.16
18FDG PET/CT D5
Group
Value
95% CI
Tumor Burden Volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT
51.79
29.17 – 103.26
Number of Patient With Concordance Between the 89Zr-TLX250 PET/CT Uptake and CAIX Histological ExpressionSecondary· 5 days
Number of patients with a concordance between the 89Zr-TLX250 PET/CT uptake and CAIX histological expression considered as positive or negative
Group
Value
95% CI
Number of Patients With Concordance Between the 89Zr-TLX250 PET and CAIX Histological Expression
7
Number of Patients With no Concordance Between the 89Zr-TLX250 PET and CAIX Histological Expression
5
Number of Participants With Adverse Events Related to 89Zr-TLX250Secondary· 30 days
All Adverse Events related to 89Zr-TLX250 are reported and assessed using CTCAE v5.0 scale
Group
Value
95% CI
Number of Participants With Adverse Events Related to 89Zr-TLX250
0
Number of Participants With Serious Adverse Events Related or Not to 89Zr-TLX250Secondary· 30 days
All Serious Adverse Events are collected between the 89Zr-TLX250 administration and 30 days after. They assessed using CTCAE v5.0 scale
Group
Value
95% CI
Number of Participants With Serious Adverse Events Related or Not to 89Zr-TLX250
0
Number of Breast Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CTPrimary· 5 days
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
89Zr-TLX250 PET/CT
Group
Value
95% CI
Number of Breast Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
25
18FDG PET/CT
Group
Value
95% CI
Number of Breast Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
23
Number of Bone Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CTPrimary· 5 days
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
89Zr-TLX250 PET/CT
Group
Value
95% CI
Number of Bone Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
102
18FDG PET/CT
Group
Value
95% CI
Number of Bone Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
111
Number of Lymph Nodes Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CTPrimary· 5 days
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
89Zr-TLX250 PET/CT
Group
Value
95% CI
Number of Lymph Nodes Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
65
18FDG PET/CT
Group
Value
95% CI
Number of Lymph Nodes Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
74
Number of Lung Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CTPrimary· 5 days
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
89Zr-TLX250 PET/CT
Group
Value
95% CI
Number of Lung Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
17
18FDG PET/CT
Group
Value
95% CI
Number of Lung Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
27
Number of Liver Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CTPrimary· 5 days
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
89Zr-TLX250 PET/CT
Group
Value
95% CI
Number of Liver Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
12
18FDG PET/CT
Group
Value
95% CI
Number of Liver Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
19
Sponsor's own 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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04897763 — Assessment of Safety, Tolerability, Radiation Dosimetry, Imaging Properties of 89Zr-girentuximab in Patients With NMIBC
· EARLY_PHASE1
· completed
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Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Institut Cancerologie de l'Ouest
Last refreshed: 5 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04758780.