Trial Outcomes & Findings for Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection (NCT NCT04838626)
NCT ID: NCT04838626
Last Updated: 2025-10-07
Results Overview
Sensitivity of vidoflufolastat (18F) Positron Emission Tomography (PET) imaging, considering Prostate Specific Membrane Antigen (PSMA) positive patients as those who show at least one pathological vidoflufolastat (18F) uptake either in the primary tumor and/or metastatic Pelvic Lymph Node (PLN) regions, with anatomically localized correspondence with the Standard of Truth (SoT).
COMPLETED
PHASE2/PHASE3
195 participants
vidoflufolastat (18F)7 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scan
2025-10-07
Participant Flow
195 patients were enrolled. 184 participants received vidoflufolastat (18F) and 184 underwent PET/CT. 173 patients completed the study and 184 patients completed treatment.
Participant milestones
| Measure |
PET/CT Imaging With Vidoflufolastat (18F).
Single intravenous dose of approximately 370 Mega-Becquerel (MBq) on Day 1 and subsequent PET/CT scan
|
|---|---|
|
Overall Study
STARTED
|
195
|
|
Overall Study
Participants Who Received Vidoflufolastat (18F) and Underwent PET/CT
|
184
|
|
Overall Study
COMPLETED
|
173
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
PET/CT Imaging With Vidoflufolastat (18F).
Single intravenous dose of approximately 370 Mega-Becquerel (MBq) on Day 1 and subsequent PET/CT scan
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Physician Decision
|
6
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Technical Problems
|
2
|
Baseline Characteristics
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
Baseline characteristics by cohort
| Measure |
PET/CT Imaging With Vidoflufolastat (18F).
n=195 Participants
Single intravenous dose of approximately 370 Mega-Becquerel (MBq) on Day 1 and subsequent PET/CT scan
|
|---|---|
|
Age, Continuous
|
64.5 Years
STANDARD_DEVIATION 6.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
195 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
122 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
192 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: vidoflufolastat (18F)7 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scanPopulation: The Efficacy Analysis Set (EFF) included all enrolled participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan and histopathology assessment, and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery.
Sensitivity of vidoflufolastat (18F) Positron Emission Tomography (PET) imaging, considering Prostate Specific Membrane Antigen (PSMA) positive patients as those who show at least one pathological vidoflufolastat (18F) uptake either in the primary tumor and/or metastatic Pelvic Lymph Node (PLN) regions, with anatomically localized correspondence with the Standard of Truth (SoT).
Outcome measures
| Measure |
Central Reader 1
n=172 Participants
Central Reading Center 1
|
Central Reader 2
n=172 Participants
Central Reading Center 2
|
Central Reader 3
n=172 Participants
Central Reading Center 3
|
|---|---|---|---|
|
Patient-level Sensitivity of Vidoflufolastat (18F) - % Sensitivity
|
86.8 % Sensitivity
Interval 80.74 to 91.56
|
90.0 % Sensitivity
Interval 84.47 to 94.07
|
86.9 % Sensitivity
Interval 80.85 to 91.61
|
PRIMARY outcome
Timeframe: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scanPopulation: The Efficacy Analysis Set (EFF) included all enrolled participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan and histopathology assessment, and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery.
Specificity of vidoflufolastat (18F) PET imaging, defined as proportion of PLN regions that test negative for lymph nodes on vidoflufolastat (18F) among those that are lymph node negative on the SoT.
Outcome measures
| Measure |
Central Reader 1
n=172 Participants
Central Reading Center 1
|
Central Reader 2
n=172 Participants
Central Reading Center 2
|
Central Reader 3
n=172 Participants
Central Reading Center 3
|
|---|---|---|---|
|
Region-level Specificity of Vidoflufolastat (18F) - % Specificity
|
97.1 % Specificity
Interval 92.74 to 99.2
|
97.1 % Specificity
Interval 92.74 to 99.2
|
97.1 % Specificity
Interval 92.74 to 99.2
|
SECONDARY outcome
Timeframe: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scanPopulation: The Efficacy Analysis Set (EFF) included all enrolled participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan and histopathology assessment, and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery.
Specificity of vidoflufolastat (18F) PET imaging, considering PSMA negative patients as those who do not show any pathological vidoflufolastat (18F) uptake either in the primary tumor or PLNs and will be confirmed not having primary tumor or metastatic PLNs with the SoT
Outcome measures
| Measure |
Central Reader 1
n=172 Participants
Central Reading Center 1
|
Central Reader 2
n=172 Participants
Central Reading Center 2
|
Central Reader 3
n=172 Participants
Central Reading Center 3
|
|---|---|---|---|
|
Patient-level Specificity of Vidoflufolastat (18F) - % Specificity
|
20.0 % Specificity
Interval 0.51 to 71.64
|
0.0 % Specificity
Interval 0.0 to 84.19
|
25.0 % Specificity
Interval 0.63 to 80.59
|
SECONDARY outcome
Timeframe: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scanPopulation: The Efficacy Analysis Set (EFF) included all enrolled participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan and histopathology assessment, and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery.
Proportion of patients who are both vidoflufolastat (18F) and SoT positive (true positives (TP) among those who test positive on vidoflufolastat (18F) (TP+ false positives (FP))
Outcome measures
| Measure |
Central Reader 1
n=172 Participants
Central Reading Center 1
|
Central Reader 2
n=172 Participants
Central Reading Center 2
|
Central Reader 3
n=172 Participants
Central Reading Center 3
|
|---|---|---|---|
|
Patient-level Positive Predictive Value of Vidoflufolastat (18F)
|
97.3 % Positive Predictive Value
Interval 93.27 to 99.26
|
98.7 % Positive Predictive Value
Interval 95.42 to 99.84
|
98.0 % Positive Predictive Value
Interval 94.23 to 99.58
|
SECONDARY outcome
Timeframe: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scanPopulation: The Efficacy Analysis Set (EFF) included all enrolled participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan and histopathology assessment, and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery.
Proportion of patients who are both vidoflufolastat (18F) and SoT negative (true negatives (TN)) among those who test negative on vidoflufolastat (18F) (TN+ false negatives (FN))
Outcome measures
| Measure |
Central Reader 1
n=172 Participants
Central Reading Center 1
|
Central Reader 2
n=172 Participants
Central Reading Center 2
|
Central Reader 3
n=172 Participants
Central Reading Center 3
|
|---|---|---|---|
|
Patient-level Negative Predictive Value of Vidoflufolastat (18F)
|
4.3 % Negative Predictive Value
Interval 0.11 to 21.95
|
0.0 % Negative Predictive Value
Interval 0.0 to 19.51
|
4.3 % Negative Predictive Value
Interval 0.11 to 21.95
|
SECONDARY outcome
Timeframe: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scanPopulation: The Efficacy Analysis Set (EFF) included all enrolled participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan and histopathology assessment, and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery.
Proportion of patients that are SoT and vidoflufolastat (18F) positive (TP) and negative (TN) among all patients in Efficacy Analysis Set (EFF) (TP+TN+FP+FN)
Outcome measures
| Measure |
Central Reader 1
n=172 Participants
Central Reading Center 1
|
Central Reader 2
n=172 Participants
Central Reading Center 2
|
Central Reader 3
n=172 Participants
Central Reading Center 3
|
|---|---|---|---|
|
Patient-level Accuracy of Vidoflufolastat (18F)
|
84.9 % Accuracy
Interval 78.64 to 89.88
|
89.0 % Accuracy
Interval 83.29 to 93.22
|
85.5 % Accuracy
Interval 79.3 to 90.37
|
SECONDARY outcome
Timeframe: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scanPopulation: The Efficacy Analysis Set (EFF) included all enrolled participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan and histopathology assessment, and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery.
Proportion of PLN regions that test positive on both vidoflufolastat (18F) and SoT (TP) among those that are SoT positive (TP+FN)
Outcome measures
| Measure |
Central Reader 1
n=172 Participants
Central Reading Center 1
|
Central Reader 2
n=172 Participants
Central Reading Center 2
|
Central Reader 3
n=172 Participants
Central Reading Center 3
|
|---|---|---|---|
|
Region-level Sensitivity of Vidoflufolastat (18F) - % Sensitivity
|
20.6 % Sensitivity
Interval 8.7 to 37.9
|
20.6 % Sensitivity
Interval 8.7 to 37.9
|
23.5 % Sensitivity
Interval 10.75 to 41.17
|
SECONDARY outcome
Timeframe: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scanPopulation: The Efficacy Analysis Set (EFF) included all enrolled participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan and histopathology assessment, and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery.
Proportion of Pelvic Lymph Node (PLN) regions that are Standard of Truth (SoT) and vidoflufolastat (18F) positive (TP) among those regions that test positive on vidoflufolastat (18F) (TP+False Positive (FP))
Outcome measures
| Measure |
Central Reader 1
n=172 Participants
Central Reading Center 1
|
Central Reader 2
n=172 Participants
Central Reading Center 2
|
Central Reader 3
n=172 Participants
Central Reading Center 3
|
|---|---|---|---|
|
Region-level Positive Predictive Value of Vidoflufolastat (18F)
|
63.6 % Positive Predictive Value
Interval 30.79 to 89.07
|
63.6 % Positive Predictive Value
Interval 30.79 to 89.07
|
66.7 % Positive Predictive Value
Interval 34.89 to 90.08
|
SECONDARY outcome
Timeframe: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scanPopulation: The Efficacy Analysis Set (EFF) included all enrolled participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan and histopathology assessment, and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery.
Proportion of PLN regions that are SoT and vidoflufolastat (18F) negative (TN) among those regions that test negative on vidoflufolastat (18F) (TN+FN)
Outcome measures
| Measure |
Central Reader 1
n=172 Participants
Central Reading Center 1
|
Central Reader 2
n=172 Participants
Central Reading Center 2
|
Central Reader 3
n=172 Participants
Central Reading Center 3
|
|---|---|---|---|
|
Region-level Negative Predictive Value of Vidoflufolastat (18F)
|
83.2 % Negative Predictive Value
Interval 76.55 to 88.65
|
83.2 % Negative Predictive Value
Interval 76.55 to 88.65
|
83.8 % Negative Predictive Value
Interval 77.1 to 89.1
|
SECONDARY outcome
Timeframe: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scanPopulation: The Efficacy Analysis Set (EFF) included all enrolled participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan and histopathology assessment, and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery.
Proportion of PLN regions that are SoT and vidoflufolastat (18F) positive (TP) and negative (TN) among all PLN regions assessed vidoflufolastat (18F)(TP+TN+FP+FN)
Outcome measures
| Measure |
Central Reader 1
n=172 Participants
Central Reading Center 1
|
Central Reader 2
n=172 Participants
Central Reading Center 2
|
Central Reader 3
n=172 Participants
Central Reading Center 3
|
|---|---|---|---|
|
Region-level Accuracy of Vidoflufolastat (18F)
|
82.0 % Accuracy
Interval 75.4 to 87.41
|
82.0 % Accuracy
Interval 75.4 to 87.41
|
82.6 % Accuracy
Interval 76.05 to 87.91
|
SECONDARY outcome
Timeframe: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scanPopulation: The Efficacy Analysis Set (EFF) included all enrolled participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan and histopathology assessment, and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery.
Sensitivity of vidoflufolastat (18F) PET imaging in the PLN region, excluding from the analysis those lymph nodes showing metastasis \<2mm (micro-metastasis)
Outcome measures
| Measure |
Central Reader 1
n=172 Participants
Central Reading Center 1
|
Central Reader 2
n=172 Participants
Central Reading Center 2
|
Central Reader 3
n=172 Participants
Central Reading Center 3
|
|---|---|---|---|
|
Region-level Sensitivity of Vidoflufolastat (18F) Scan With Standard of Truth Excluding Pelvic Lymph Node (PLN) Metastasis < 2 mm
|
26.9 % Sensitivity
Interval 11.57 to 47.79
|
26.9 % Sensitivity
Interval 11.57 to 47.79
|
30.8 % Sensitivity
Interval 14.33 to 51.79
|
SECONDARY outcome
Timeframe: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scanPopulation: Safety set - all treated patients
Number of distant metastasis identified at PET/CT scan in all patients, and percentage of patients with at least one distant metastatic lesion (extra-PLN, visceral or skeletal)identified by PET scan in all patients with an evaluable vidoflufolastat (18F) PET/CT scan.
Outcome measures
| Measure |
Central Reader 1
n=184 Participants
Central Reading Center 1
|
Central Reader 2
n=184 Participants
Central Reading Center 2
|
Central Reader 3
n=184 Participants
Central Reading Center 3
|
|---|---|---|---|
|
Detection of Distant Metastasis of Vidoflufolastat (18F) Scan - Participants With at Least One Distant Metastatic Lesion (%)
|
6 Participants
|
9 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.Population: Safety set - all treated patients
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject
Outcome measures
| Measure |
Central Reader 1
n=184 Participants
Central Reading Center 1
|
Central Reader 2
Central Reading Center 2
|
Central Reader 3
Central Reading Center 3
|
|---|---|---|---|
|
Overview of Adverse Events
Fatal serious adverse events
|
0 Participants
|
—
|
—
|
|
Overview of Adverse Events
Adverse events
|
24 Participants
|
—
|
—
|
|
Overview of Adverse Events
Treatment-related Adverse events
|
1 Participants
|
—
|
—
|
|
Overview of Adverse Events
Serious adverse events
|
2 Participants
|
—
|
—
|
|
Overview of Adverse Events
Serious adverse events Treatment-related
|
0 Participants
|
—
|
—
|
|
Overview of Adverse Events
Fatal serious adverse events Treatment-related
|
0 Participants
|
—
|
—
|
|
Overview of Adverse Events
Adverse events leading to dose adjustment / interruption
|
0 Participants
|
—
|
—
|
|
Overview of Adverse Events
Adverse events requiring additional therapy
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scanPopulation: Safety set - all treated patients
Scan inter-reader variability is defined the agreement rate among reader determination of vidoflufolastat (18F) images.
Outcome measures
| Measure |
Central Reader 1
n=184 Participants
Central Reading Center 1
|
Central Reader 2
Central Reading Center 2
|
Central Reader 3
Central Reading Center 3
|
|---|---|---|---|
|
Vidoflufolastat (18F) Scan Inter-reader Variability - %
|
63.9 % variability
Interval 55.52 to 72.2
|
—
|
—
|
SECONDARY outcome
Timeframe: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scanPopulation: Safety set - all treated patients
Scan inter-reader variability is defined the agreement rate among reader determination of vidoflufolastat (18F) images.
Outcome measures
| Measure |
Central Reader 1
n=184 Participants
Central Reading Center 1
|
Central Reader 2
Central Reading Center 2
|
Central Reader 3
Central Reading Center 3
|
|---|---|---|---|
|
Vidoflufolastat (18F) Scan Inter-reader Variability - Number of Scans Agreed
Number of scans agreed by all three readers
|
163 Participants
|
—
|
—
|
|
Vidoflufolastat (18F) Scan Inter-reader Variability - Number of Scans Agreed
Number of scans agreed by two readers
|
21 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: vidoflufolastat (18F) PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from vidoflufolastat (18F) scanPopulation: Safety set - all treated patients with a valid measurement. For this outcome measure, scans for a subset of 20 patients were read by each reader at 2 different time points.
Scan intra-reader variability is defined as the within-reader agreement rate of vidoflufolastat (18F) images.
Outcome measures
| Measure |
Central Reader 1
n=20 Participants
Central Reading Center 1
|
Central Reader 2
n=20 Participants
Central Reading Center 2
|
Central Reader 3
n=20 Participants
Central Reading Center 3
|
|---|---|---|---|
|
Vidoflufolastat (18F) Scan Intra-reader Variability
|
100 variability (%)
Interval 100.0 to 100.0
|
100 variability (%)
Interval 100.0 to 100.0
|
89.4 variability (%)
Interval 69.0 to 100.0
|
SECONDARY outcome
Timeframe: Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)Population: The Pharmacokinetic analysis set (PAS) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)) with valid results for the outcome measure. For PK outcome measures, a subset of 10 patients maximum were analyzed.
Outcome measures
| Measure |
Central Reader 1
n=10 Participants
Central Reading Center 1
|
Central Reader 2
Central Reading Center 2
|
Central Reader 3
Central Reading Center 3
|
|---|---|---|---|
|
Observed Maximum Blood Concentration (Cmax) of Vidoflufolastat (18F)
|
49.0 kBq/mL
Standard Deviation 19.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)Population: The Pharmacokinetic analysis set (PAS) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)) with valid results for the outcome measure. For PK outcome measures, a subset of 10 patients maximum were analyzed.
Outcome measures
| Measure |
Central Reader 1
n=10 Participants
Central Reading Center 1
|
Central Reader 2
Central Reading Center 2
|
Central Reader 3
Central Reading Center 3
|
|---|---|---|---|
|
Time of Maximum Observed Blood Concentration Occurrence (Tmax) of Vidoflufolastat (18F)
|
0.0333 Hours
Interval 0.0167 to 0.0833
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)Population: The Pharmacokinetic analysis set (PAS) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)) with valid results for the outcome measure. For PK outcome measures, a subset of 10 patients maximum were analyzed.
Outcome measures
| Measure |
Central Reader 1
n=10 Participants
Central Reading Center 1
|
Central Reader 2
Central Reading Center 2
|
Central Reader 3
Central Reading Center 3
|
|---|---|---|---|
|
Area Under the Vidoflufolastat (18F) Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast)
|
47.9 h*kBq/mL
Standard Deviation 11.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post infusion)Population: The Pharmacokinetic analysis set (PAS) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)) with valid results for the outcome measure. For PK outcome measures, a subset of 10 patients maximum were analyzed. For this parameter, results for only 1 pt were evaluable.
Outcome measures
| Measure |
Central Reader 1
n=1 Participants
Central Reading Center 1
|
Central Reader 2
Central Reading Center 2
|
Central Reader 3
Central Reading Center 3
|
|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUCinf) of Vidoflufolastat (18F)
|
50.0 h*kBq/mL
Standard Deviation NA
not applicable when n = 1
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)Population: The Pharmacokinetic analysis set (PAS) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)) with valid results for the outcome measure. For PK outcome measures, a subset of 10 patients maximum were analyzed. For this parameter, results for only 1 pt were evaluable.
Outcome measures
| Measure |
Central Reader 1
n=1 Participants
Central Reading Center 1
|
Central Reader 2
Central Reading Center 2
|
Central Reader 3
Central Reading Center 3
|
|---|---|---|---|
|
Half-Life Lambda z of Vidoflufolastat (18F)
|
1.34 h
Standard Deviation NA
not applicable when n = 1
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)Population: The Pharmacokinetic analysis set (PAS) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)) with valid results for the outcome measure. For PK outcome measures, a subset of 10 patients maximum were analyzed. For this parameter, results for only 1 pt were evaluable.
Outcome measures
| Measure |
Central Reader 1
n=1 Participants
Central Reading Center 1
|
Central Reader 2
Central Reading Center 2
|
Central Reader 3
Central Reading Center 3
|
|---|---|---|---|
|
Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) of Vidoflufolastat (18F)
|
14.9 L
Standard Deviation NA
not applicable when n = 1
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-injection/0 hour, 0 hour (injection) - T (image acquisition starting time), T (image acquisition starting time) to 3 hours, 3 hours to 5 hours post imaging)Population: The Pharmacokinetic analysis set (PAS) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)) with valid results for the outcome measure. For PK outcome measures, a subset of 10 patients maximum were analyzed.
Outcome measures
| Measure |
Central Reader 1
n=10 Participants
Central Reading Center 1
|
Central Reader 2
Central Reading Center 2
|
Central Reader 3
Central Reading Center 3
|
|---|---|---|---|
|
Urinary Excretion of Radioactivity Expressed as a Percentage of Injected Activity (%IA) of Vidoflufolastat (18F)
0 HRS (INJECTION) - T (IMAGE ACQUISITION STARTING TIME)
|
15.8 %IA
Standard Deviation 11.9
|
—
|
—
|
|
Urinary Excretion of Radioactivity Expressed as a Percentage of Injected Activity (%IA) of Vidoflufolastat (18F)
IMAGE ACQUISITION STARTING TIME T - 3 H
|
11.9 %IA
Standard Deviation 8.30
|
—
|
—
|
|
Urinary Excretion of Radioactivity Expressed as a Percentage of Injected Activity (%IA) of Vidoflufolastat (18F)
0 HRS INJECTION/PRE-INJECTION
|
0.000821 %IA
Standard Deviation 0.00120
|
—
|
—
|
|
Urinary Excretion of Radioactivity Expressed as a Percentage of Injected Activity (%IA) of Vidoflufolastat (18F)
3 H - 5 H
|
10.5 %IA
Standard Deviation 8.06
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (0, 0-5, 15, 30, 60, 120, 180-240, 300 minutes post injection)Population: The Pharmacokinetic analysis set (PAS) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)) with valid results for the outcome measure. For PK outcome measures, a subset of 10 patients maximum were analyzed. For this parameter, results for only 1 pt were evaluable.
Outcome measures
| Measure |
Central Reader 1
n=1 Participants
Central Reading Center 1
|
Central Reader 2
Central Reading Center 2
|
Central Reader 3
Central Reading Center 3
|
|---|---|---|---|
|
Total Systemic Clearance for Intravenous Administration (CL) of Vidoflufolastat (18F)
|
7.70 L/h
Standard Deviation NA
not applicable when n = 1
|
—
|
—
|
Adverse Events
PET/CT Imaging With Vidoflufolastat (18F)
Serious adverse events
| Measure |
PET/CT Imaging With Vidoflufolastat (18F)
n=184 participants at risk
Single intravenous dose of approximately 370 Mega-Becquerel (MBq) on Day 1 and subsequent PET/CT scan
|
|---|---|
|
Cardiac disorders
Myocardial ischaemia
|
0.54%
1/184 • Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.
|
|
Infections and infestations
Sepsis syndrome
|
0.54%
1/184 • Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.
|
Other adverse events
| Measure |
PET/CT Imaging With Vidoflufolastat (18F)
n=184 participants at risk
Single intravenous dose of approximately 370 Mega-Becquerel (MBq) on Day 1 and subsequent PET/CT scan
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.54%
1/184 • Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.54%
1/184 • Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.
|
|
General disorders
Asthenia
|
0.54%
1/184 • Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.
|
|
General disorders
Feeling hot
|
0.54%
1/184 • Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.
|
|
General disorders
Pyrexia
|
0.54%
1/184 • Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.
|
|
Infections and infestations
COVID-19
|
0.54%
1/184 • Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.
|
|
Infections and infestations
Oral herpes
|
0.54%
1/184 • Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.
|
|
Investigations
Amylase increased
|
0.54%
1/184 • Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.54%
1/184 • Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.
|
|
Nervous system disorders
Dizziness
|
1.1%
2/184 • Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.
|
|
Nervous system disorders
Headache
|
0.54%
1/184 • Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.54%
1/184 • Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.
|
|
Nervous system disorders
Presyncope
|
1.1%
2/184 • Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.
|
|
Psychiatric disorders
Insomnia
|
0.54%
1/184 • Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.54%
1/184 • Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.54%
1/184 • Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.54%
1/184 • Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.54%
1/184 • Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.54%
1/184 • Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.
|
|
Vascular disorders
Hot flush
|
0.54%
1/184 • Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.
|
|
Vascular disorders
Hypertension
|
2.7%
5/184 • Adverse Events are reported from the single dose of study treatment administration until 14 days afterwards, for a maximum time frame of approx. 14 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER