Trial Outcomes & Findings for 89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study (NCT NCT03849118)
NCT ID: NCT03849118
Last Updated: 2024-05-17
Results Overview
This outcome was evaluated on all patients by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This was compared against the histological determination of the lesion type following resection of the lesion
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
300 participants
Primary outcome timeframe
Diagnostic PET/CT scan on Day 5 ± 2 days post 89Zr-TLX250 administration. Histological confirmation of the material from nephrectomy conducted within 90 days post 89Zr-TLX250 administration served as standard of truth.
Results posted on
2024-05-17
Participant Flow
Participant milestones
| Measure |
89Zr-girentuximab
A single administration of 37 Megabecquerel (MBq) (±10%) 89Zr-girentuximab, containing a mass dose of 10 mg of girentuximab, followed by a diagnostic scan on Day 5 ± 2 days after administration.
89Zr-girentuximab: Single IV administration on Day 0, followed by diagnostic scan on Day 5 +/- 2 days.
|
|---|---|
|
Overall Study
STARTED
|
300
|
|
Overall Study
COMPLETED
|
275
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study
Baseline characteristics by cohort
| Measure |
89Zr-girentuximab
n=300 Participants
A single administration of 37 MBq (±10%) 89Zr-TLX250, containing a mass dose of 10 mg of girentuximab followed by a diagnostic scan on Day 5 ± 2 days
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
176 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
124 Participants
n=99 Participants
|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 11.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
214 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
13 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
277 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 participants
n=99 Participants
|
|
Region of Enrollment
Canada
|
6 participants
n=99 Participants
|
|
Region of Enrollment
Netherlands
|
38 participants
n=99 Participants
|
|
Region of Enrollment
Turkey
|
29 participants
n=99 Participants
|
|
Region of Enrollment
Belgium
|
29 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
113 participants
n=99 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=99 Participants
|
|
Region of Enrollment
Australia
|
35 participants
n=99 Participants
|
|
Region of Enrollment
France
|
45 participants
n=99 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Diagnostic PET/CT scan on Day 5 ± 2 days post 89Zr-TLX250 administration. Histological confirmation of the material from nephrectomy conducted within 90 days post 89Zr-TLX250 administration served as standard of truth.Population: The overall number of participants analyzed consisted of all enrolled patients who had evaluable PET/CT imaging and a confirmed histopathology diagnosis. This number (284) is lower than the baseline participants (of 300) as 16 patients did not have both of these data points.
This outcome was evaluated on all patients by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This was compared against the histological determination of the lesion type following resection of the lesion
Outcome measures
| Measure |
89Zr-girentuximab
n=284 Participants
Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days.
|
|---|---|
|
Sensitivity and Specificity of Qualitative Assessment of PET/CT Imaging With 89Zr-TLX250 to Noninvasively Detect ccRCC in Patients With Indeterminate Renal Masses, Using Histology as Standard of Truth.
True negative
|
84 Participants
|
|
Sensitivity and Specificity of Qualitative Assessment of PET/CT Imaging With 89Zr-TLX250 to Noninvasively Detect ccRCC in Patients With Indeterminate Renal Masses, Using Histology as Standard of Truth.
False positive
|
11 Participants
|
|
Sensitivity and Specificity of Qualitative Assessment of PET/CT Imaging With 89Zr-TLX250 to Noninvasively Detect ccRCC in Patients With Indeterminate Renal Masses, Using Histology as Standard of Truth.
False negative
|
30 Participants
|
|
Sensitivity and Specificity of Qualitative Assessment of PET/CT Imaging With 89Zr-TLX250 to Noninvasively Detect ccRCC in Patients With Indeterminate Renal Masses, Using Histology as Standard of Truth.
True Positive
|
159 Participants
|
Adverse Events
Adverse Events Information
Serious events: 26 serious events
Other events: 86 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Adverse Events Information
n=300 participants at risk
The safety analysis set (SAF) consisted of all patients who received 89Zr-TLX250.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.33%
1/300 • 3 years
|
|
Cardiac disorders
Tachycardia
|
0.33%
1/300 • 3 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.33%
1/300 • 3 years
|
|
Gastrointestinal disorders
Hemoperitoneum
|
0.33%
1/300 • 3 years
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.33%
1/300 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
0.33%
1/300 • 3 years
|
|
Gastrointestinal disorders
Retroperitoneal Effusion
|
0.33%
1/300 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
0.33%
1/300 • 3 years
|
|
General disorders
Asthenia
|
0.33%
1/300 • 3 years
|
|
General disorders
Death
|
0.33%
1/300 • 3 years
|
|
General disorders
Multiple organ dysfunctional syndrome
|
0.33%
1/300 • 3 years
|
|
Hepatobiliary disorders
Ischemic Hepatitis
|
0.33%
1/300 • 3 years
|
|
Infections and infestations
Hematoma Infection
|
0.33%
1/300 • 3 years
|
|
Infections and infestations
Infection
|
0.33%
1/300 • 3 years
|
|
Infections and infestations
Klebsiella Infection
|
0.33%
1/300 • 3 years
|
|
Infections and infestations
Pneumonia
|
0.33%
1/300 • 3 years
|
|
Infections and infestations
Pyelonephritis
|
0.33%
1/300 • 3 years
|
|
Infections and infestations
Sepsis
|
0.33%
1/300 • 3 years
|
|
Injury, poisoning and procedural complications
Arterial Injury
|
0.33%
1/300 • 3 years
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.33%
1/300 • 3 years
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.33%
1/300 • 3 years
|
|
Injury, poisoning and procedural complications
Post procedural hematuria
|
0.33%
1/300 • 3 years
|
|
Injury, poisoning and procedural complications
Post procedural hemorrhage
|
2.3%
7/300 • 3 years
|
|
Injury, poisoning and procedural complications
Post procedural hypotension
|
0.33%
1/300 • 3 years
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.33%
1/300 • 3 years
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.33%
1/300 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.67%
2/300 • 3 years
|
|
Metabolism and nutrition disorders
Hypovolemia
|
0.33%
1/300 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Hematoma muscle
|
0.33%
1/300 • 3 years
|
|
Nervous system disorders
Cerebrovascular accident
|
0.33%
1/300 • 3 years
|
|
Nervous system disorders
Syncope
|
0.67%
2/300 • 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.33%
1/300 • 3 years
|
|
Renal and urinary disorders
Renal Impairment
|
0.33%
1/300 • 3 years
|
|
Renal and urinary disorders
Subcapsular renal hematoma
|
0.33%
1/300 • 3 years
|
|
Renal and urinary disorders
Urinary retention
|
0.67%
2/300 • 3 years
|
|
Renal and urinary disorders
Urinoma
|
0.33%
1/300 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary edema
|
0.33%
1/300 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.33%
1/300 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.33%
1/300 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.67%
2/300 • 3 years
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.33%
1/300 • 3 years
|
|
Vascular disorders
Arteriosclerosis
|
0.33%
1/300 • 3 years
|
|
Vascular disorders
Hypotension
|
0.33%
1/300 • 3 years
|
Other adverse events
| Measure |
Adverse Events Information
n=300 participants at risk
The safety analysis set (SAF) consisted of all patients who received 89Zr-TLX250.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
1.7%
5/300 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
2.7%
8/300 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
2.7%
8/300 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
3.7%
11/300 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
6/300 • 3 years
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.7%
11/300 • 3 years
|
|
Vascular disorders
Hypertension
|
2.0%
6/300 • 3 years
|
|
Nervous system disorders
Headache
|
3.0%
9/300 • 3 years
|
|
General disorders
Fatigue
|
2.7%
8/300 • 3 years
|
|
General disorders
Pain
|
2.3%
7/300 • 3 years
|
|
Infections and infestations
Urinary tract infection
|
2.3%
7/300 • 3 years
|
Additional Information
Dr. Kavita Vadali, Sr. Clinical Project Manager
Telix Pharmaceuticals (Innovations) Pty Ltd
Phone: +1 919-924-8887
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If the Study is a Multi-center Study, then the Institution agrees that no publication of the study results may be made until publication of the results of the multi-center study or 2 years after study completion, whichever is the sooner.
- Publication restrictions are in place
Restriction type: OTHER