Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000729426
Ethics application status
Approved
Date submitted
18/06/2025
Date registered
8/07/2025
Date last updated
8/07/2025
Date data sharing statement initially provided
8/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of Impact on Management by Zircaix PET/CT (AIMZ PET/CT)
Scientific title
Assessment of Impact on Management by Zircaix PET/CT in participants with suspected or proven CA-IX-expressing tumours (AIMZ PET/CT)
Secondary ID [1] 314694 0
AIMZ-001-2025
Universal Trial Number (UTN)
U1111-1324-2923
Trial acronym
AIMZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma 337875 0
Mesothelioma 337876 0
Other suspected solid tumour anticipated to express CAIX 337877 0
Condition category
Condition code
Cancer 334206 334206 0 0
Other cancer types
Cancer 334204 334204 0 0
Kidney
Cancer 334205 334205 0 0
Lung - Mesothelioma

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
12
Target follow-up type
Months
Description of intervention(s) / exposure
This is a prospective, non-randomised study involving patients who will be identified by managing clinicians and referred to the Melbourne Theranostic Innovation Centre for imaging on the Siemens Biograph Vision Quadra for suspected or proven CA-IX-expressing tumours. Patient selection will involve accruing 100 suitable patients into the following three groups:
• Group 1: 30 patients with a presumed or suspected primary diagnosis of ccRCC based on conventional imaging with ultrasound, CT or MRI, including up to 10 individuals with VHL mutation
• Group 2: 20 patients with a presumed or proven diagnosis of mesothelioma
• Group 3: 50 patients evaluated in the post-treatment setting for evaluation of residual mass lesions or assessment of therapeutic response with either ccRCC or mesothelioma or other cancers anticipated to have elevated CA-IX expression

The pretest management decision based on all other available information (treatment intention) will be recorded prior to the PET scan. The actual treatment performed will be reviewed at 6 and 12 months after the scan. The accuracy of the PET scan will be ascertained from the results of other imaging studies, pathological and surgical findings and from clinical outcome including survival. Other correlative imaging studies performed within 2 weeks of the PET and without intervening procedures or treatment that may impact comparability of the scans, will be directly compared with the PET scan to assess the accuracy with which tumour detection is achieved by each modality.
Intervention code [1] 331300 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341870 0
To evaluate the impact of 89Zr-Girentuximab PET/CT on clinical management.
Timepoint [1] 341870 0
6months and 12 months after enrolment
Secondary outcome [1] 448840 0
To determine the lesion sensitivity and specificity of 89Zr-Girentuximab PET/CT. This is a composite outcome.
Timepoint [1] 448840 0
6 months and 12 months after enrolment
Secondary outcome [2] 448842 0
Lesion malignancy on 89Zr-Girentuximab PET/CT
Timepoint [2] 448842 0
6 months and 12 months after enrolment
Secondary outcome [3] 448841 0
Lesion uptake on 89Zr-Girentuximab PET/CT
Timepoint [3] 448841 0
Time of scanning

Eligibility
Key inclusion criteria
• Referred for an 89Zr-girentuximab PET/CT for clinical evaluation.
• For evaluation of histologically proven or strongly suspected malignancy of one of the following types:
o Clear cell renal cell carcinoma (ccRCC)
o Mesothelioma
o Other suspected solid tumour anticipated to express CA-IX
• The patient must have a defined management plan provided by the referring clinician prior to performance of the PET scan.
• The patient must be 18 or older.
• Patient must be able to provide informed consent.
• Expected survival >3 months.
• ECOG status <4.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Is unable to understand or is unwilling to sign a written informed consent documents or to follow investigational procedures in the opinion of the investigator.
• The patient is pregnant or breast feeding.
• Patient is unable to lie supine at least 15 minutes while having the PET scan.
• Has known allergies, hypersensitivity, or intolerance to the investigational drug or its excipients.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
25/01/2027
Actual
Date of last data collection
Anticipated
31/01/2028
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 44322 0
3051 - North Melbourne

Funding & Sponsors
Funding source category [1] 319243 0
Commercial sector/Industry
Name [1] 319243 0
Telix Pharmaceuticals
Country [1] 319243 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Theranostic Innovation Centre
Address
Country
Australia
Secondary sponsor category [1] 321830 0
None
Name [1] 321830 0
Address [1] 321830 0
Country [1] 321830 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317823 0
Bellberry Human Research Ethics Committee G
Ethics committee address [1] 317823 0
Ethics committee country [1] 317823 0
Australia
Date submitted for ethics approval [1] 317823 0
16/04/2025
Approval date [1] 317823 0
12/06/2025
Ethics approval number [1] 317823 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142266 0
Prof Rodney Hicks
Address 142266 0
Melbourne Theranostic Innovation Centre. Level 8, 14-20 Blackwood St. North Melbourne, VIC 3051
Country 142266 0
Australia
Phone 142266 0
+61 03 9454 5804
Fax 142266 0
Email 142266 0
[email protected]
Contact person for public queries
Name 142267 0
Christopher Marinakis
Address 142267 0
Melbourne Theranostic Innovation Centre. Level 8, 14-20 Blackwood St. North Melbourne, VIC 3051
Country 142267 0
Australia
Phone 142267 0
+61 03 9454 5800
Fax 142267 0
Email 142267 0
[email protected]
Contact person for scientific queries
Name 142268 0
Jason Callahan
Address 142268 0
Melbourne Theranostic Innovation Centre. Level 8, 14-20 Blackwood St. North Melbourne, VIC 3051
Country 142268 0
Australia
Phone 142268 0
+61 03 9454 5800
Fax 142268 0
Email 142268 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.