Trial Outcomes & Findings for Imaging Performance Assessment of 89Zi-girentuximab (89Zr-TLX250) PET in Metastatic Triple Negative Breast Cancer (NCT NCT04758780)
NCT ID: NCT04758780
Last Updated: 2025-12-30
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
5 days
Results posted on
2025-12-30
Participant Flow
Participant milestones
| Measure |
89Zr-TLX250 PET/CT
Pretherapeutic 89Zr-TLX250 PET/CT
89Zr-TLX250 PET/CT: Pretherapeutic 89Zr-TLX250 PET/CT
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
89Zr-TLX250 PET/CT
n=12 Participants
Pretherapeutic 89Zr-TLX250 PET/CT
89Zr-TLX250 PET/CT: Pretherapeutic 89Zr-TLX250 PET/CT
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=12 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=12 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=12 Participants
|
|
Age, Continuous
|
68 years
n=12 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=12 Participants
|
|
Region of Enrollment
France
|
12 participants
n=12 Participants
|
PRIMARY outcome
Timeframe: 5 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
Outcome measures
| Measure |
tumor burden volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT
n=273 all lesions
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)
|
Number of patients with no concordance between the 89Zr-TLX250 PET and CAIX histological expression
Number of patients with no concordance between the 89Zr-TLX250 PET/CT uptake and CAIX histological expression considered as positive or negative
|
|---|---|---|
|
Number of Total Lesions Detected on 89Zr-TLX250 PET/CT Versus 18FDG PET/CT
18FDG PET/CT
|
264 lesions
|
—
|
|
Number of Total Lesions Detected on 89Zr-TLX250 PET/CT Versus 18FDG PET/CT
89Zr-TLX250 PET/CT
|
231 lesions
|
—
|
PRIMARY outcome
Timeframe: 5 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 on 18FDG PET/CT
Outcome measures
| Measure |
tumor burden volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT
n=3 lesions
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)
|
Number of patients with no concordance between the 89Zr-TLX250 PET and CAIX histological expression
Number of patients with no concordance between the 89Zr-TLX250 PET/CT uptake and CAIX histological expression considered as positive or negative
|
|---|---|---|
|
Number of Brain Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
89Zr-TLX250 PET/CT
|
3 lesions
|
—
|
|
Number of Brain Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
18FDG PET/CT
|
1 lesions
|
—
|
PRIMARY outcome
Timeframe: 5 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
Outcome measures
| Measure |
tumor burden volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT
n=25 lesions
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)
|
Number of patients with no concordance between the 89Zr-TLX250 PET and CAIX histological expression
Number of patients with no concordance between the 89Zr-TLX250 PET/CT uptake and CAIX histological expression considered as positive or negative
|
|---|---|---|
|
Number of Breast Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
89Zr-TLX250 PET/CT
|
25 lesions
|
—
|
|
Number of Breast Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
18FDG PET/CT
|
23 lesions
|
—
|
PRIMARY outcome
Timeframe: 5 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
Outcome measures
| Measure |
tumor burden volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT
n=112 lesions
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)
|
Number of patients with no concordance between the 89Zr-TLX250 PET and CAIX histological expression
Number of patients with no concordance between the 89Zr-TLX250 PET/CT uptake and CAIX histological expression considered as positive or negative
|
|---|---|---|
|
Number of Bone Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
89Zr-TLX250 PET/CT
|
102 lesions
|
—
|
|
Number of Bone Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
18FDG PET/CT
|
111 lesions
|
—
|
PRIMARY outcome
Timeframe: 5 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
Outcome measures
| Measure |
tumor burden volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT
n=78 lesions
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)
|
Number of patients with no concordance between the 89Zr-TLX250 PET and CAIX histological expression
Number of patients with no concordance between the 89Zr-TLX250 PET/CT uptake and CAIX histological expression considered as positive or negative
|
|---|---|---|
|
Number of Lymph Nodes Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
89Zr-TLX250 PET/CT
|
65 lesions
|
—
|
|
Number of Lymph Nodes Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
18FDG PET/CT
|
74 lesions
|
—
|
PRIMARY outcome
Timeframe: 5 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
Outcome measures
| Measure |
tumor burden volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT
n=27 lesions
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)
|
Number of patients with no concordance between the 89Zr-TLX250 PET and CAIX histological expression
Number of patients with no concordance between the 89Zr-TLX250 PET/CT uptake and CAIX histological expression considered as positive or negative
|
|---|---|---|
|
Number of Lung Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
89Zr-TLX250 PET/CT
|
17 lesions
|
—
|
|
Number of Lung Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
18FDG PET/CT
|
27 lesions
|
—
|
PRIMARY outcome
Timeframe: 5 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
Outcome measures
| Measure |
tumor burden volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT
n=19 lesions
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)
|
Number of patients with no concordance between the 89Zr-TLX250 PET and CAIX histological expression
Number of patients with no concordance between the 89Zr-TLX250 PET/CT uptake and CAIX histological expression considered as positive or negative
|
|---|---|---|
|
Number of Liver Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
89Zr-TLX250 PET/CT
|
12 lesions
|
—
|
|
Number of Liver Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
18FDG PET/CT
|
19 lesions
|
—
|
SECONDARY outcome
Timeframe: 5 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)
Outcome measures
| Measure |
tumor burden volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT
n=273 lesions
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)
|
Number of patients with no concordance between the 89Zr-TLX250 PET and CAIX histological expression
Number of patients with no concordance between the 89Zr-TLX250 PET/CT uptake and CAIX histological expression considered as positive or negative
|
|---|---|---|
|
Tumor Burden Volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT
18FDG PET/CT D5
|
51.79 cm3
Interval 29.17 to 103.26
|
—
|
|
Tumor Burden Volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT
89Zr-TLX250 PET/CT D3
|
41.01 cm3
Interval 16.71 to 138.68
|
—
|
|
Tumor Burden Volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT
89Zr-TLX250 PET/CT D5
|
37.42 cm3
Interval 24.7 to 173.75
|
—
|
|
Tumor Burden Volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT
18FDG PET/CT D3
|
41.21 cm3
Interval 13.42 to 184.16
|
—
|
SECONDARY outcome
Timeframe: 5 daysNumber of patients with a concordance between the 89Zr-TLX250 PET/CT uptake and CAIX histological expression considered as positive or negative
Outcome measures
| Measure |
tumor burden volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT
n=12 Participants
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)
|
Number of patients with no concordance between the 89Zr-TLX250 PET and CAIX histological expression
n=12 Participants
Number of patients with no concordance between the 89Zr-TLX250 PET/CT uptake and CAIX histological expression considered as positive or negative
|
|---|---|---|
|
Number of Patient With Concordance Between the 89Zr-TLX250 PET/CT Uptake and CAIX Histological Expression
|
7 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 30 daysAll Adverse Events related to 89Zr-TLX250 are reported and assessed using CTCAE v5.0 scale
Outcome measures
| Measure |
tumor burden volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT
n=12 Participants
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)
|
Number of patients with no concordance between the 89Zr-TLX250 PET and CAIX histological expression
Number of patients with no 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-TLX250
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 daysAll Serious Adverse Events are collected between the 89Zr-TLX250 administration and 30 days after. They assessed using CTCAE v5.0 scale
Outcome measures
| Measure |
tumor burden volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT
n=12 Participants
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)
|
Number of patients with no concordance between the 89Zr-TLX250 PET and CAIX histological expression
Number of patients with no concordance between the 89Zr-TLX250 PET/CT uptake and CAIX histological expression considered as positive or negative
|
|---|---|---|
|
Number of Participants With Serious Adverse Events Related or Not to 89Zr-TLX250
|
0 Participants
|
—
|
Adverse Events
89Zr-TLX250 PET/CT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Caroline ROUSSEAU
Institut de cancérologie de l'Ouest
Phone: +33 240679900
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place