This study is investigating a new agent to be used in PET imaging for prostate cancer, called 68Ga-NTA-476. It aims to find out where 68Ga-NTA-476 goes in the body once it is injected into a person and whether there are any side effects or issues with tolerating the compound. This will be compared to an existing imaging compound which is currently used in Australia called 18F-DCFPyl. 68Ga-NTA-476 has been developed and tested in the laboratory; however, this is the first time that it will be tested in humans.
This study is investigating a new agent to be used in PET imaging for prostate cancer, called 68Ga-NTA-476. It aims to find out where 68Ga-NTA-476 goes in the body once it is injected into a person and whether there are any side effects or issues with tolerating the compound. This will be compared to an existing imaging compound which is currently used in Australia called 18F-DCFPyl. 68Ga-NTA-476 has been developed and tested in the laboratory; however, this is the first time that it will be tested in humans. Who is it for? You may be eligible for this study if you are an adult older than 18 years of age, you have been diagnosed with prostate cancer and do not have any significant other health issues. Study details All participants who choose to participate will complete a Screening Visit to make sure that they meet the eligibility requirements for the study. Procedures completed during this visit will include demographic details, medical history, physical examination, vital signs, ECG, blood samples to check overall health status and a 18F-DCFPyl PET scan. Following confirmation of eligibility, participants will complete an Imaging Day Visit. During this visit, single dose of 68Ga-NTA-476 will be injected via a vein into the body. Following this, PET scans will be completed at about 0-30 minutes, 1 hour, and 4-6 hours. Participants will be observed in the clinical for a total of 6 hours to check vital signs and record any side effects. Between 7-9 days after this, a final study visit will be completed. Blood samples will be collected to check overall health status and the research team will check to see if any side effects were experienced. A total of 10 participants will be enrolled in this study at Melbourne Theranostic Innovation Centre in Australia
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
10
The novel Prostate Specific Membrane Antigen (PSMA) targeting molecule, NTA-476, is comprised of a small peptide targeting moiety that is attached to a linker and dodecane tetraacetic acid (DOTA) cage which enables chelation of the radionuclide 68Ga for Positron Emission Tomography (PET) imaging.
Melbourne Theranostic Innovation Centre
Melbourne, Victoria, Australia
Tumour uptake of 68Ga-NTA-476 as compared to 15F-DCFPyl in participants with prostate cancer
Standardised Uptake Value (SUV)max, SUVmean and total tumour volume by PET/CT quantitation
Time frame: PET/CT scans completed at 0-30 minutes, 1 hour, and 4-6 hours following 68Ga-NTA-476 administration
To characterize the uptake and washout of 68Ga-NTA-476 in normal organs as compared to 18F-DCFPyL in participants with prostate cancer
Time Activity Curves (TACs), describing % of the injected activity vs time will be derived for selected organs and tumours
Time frame: PET/CT scans completed at 0-30 minutes, 1 hour, and 4-6 hours following 68Ga-NTA-476 administration
To assess the safety and tolerability of a single dose of 68Ga-NTA-476
Safety is evaluated with the properties, incidence, nature and severity of AEs and SAEs, abnormal laboratory parameters, vital signs, and electrocardiogram (ECG) results per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: Safety will be assessed on the Imaging Day in the clinic during observation for up to 6 hours post injection of 68Ga-NTA-476 and followed up for a total of 1 week following administration.
To explore the dosimetry of 68Ga-NTA-476
Absorbed radiation doses of 68Ga-NTA-476 in critical organs (e.g., kidneys, bone marrow)
Time frame: PET/CT scans completed at 0-30 minutes, 1 hour, and 4-6 hours following 68Ga-NTA-476 administration
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