Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06520449
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-21
Brief Title:
68Ga-NTA-476 Imaging in Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-Arm Comparative Imaging Study of 68Ga-NTA-476 PETCT Compared to Standard of Care 18F-DCFPyL PETCT in Men With Prostate Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NTA-476
Brief Summary:
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None