Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04831307
Status:
UNKNOWN
Last Update Posted:
2021-12-03
First Post:
2021-04-01
Brief Title:
68Ga-HTK03149 for Use as a Diagnostic Radiopharmaceutical
Sponsor:
British Columbia Cancer Agency
Organization:
British Columbia Cancer Agency
Study Overview
Official Title:
Evaluation of the in Vivo Biodistribution and Radiation Dosimetry of 68Ga-HTK03149 for Use as a Diagnostic Radiopharmaceutical
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a preliminary evaluation of a radiotracers biodistribution in human subjects It is a prospective single-centre open-label single group assignment interventional study
Prostate cancer is very common and PSMA imaging is currently the most accurate means of localizing these tumours
The goal is to evaluate the biodistribution and safety of 68GaHTK03149 PETCT for prostate cancer imaging
Prostate cancer is very common and PSMA imaging is currently the most accurate means of localizing these tumours
The goal is to evaluate the biodistribution and safety of 68GaHTK03149 PETCT for prostate cancer imaging
Detailed Description:
Each subject will have a PETCT scan using 68GaHTK03149 The 68GaHTK03149 radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada
After providing informed written consent subjects will complete a medical history questionnaire
Monitoring of adverse events There will be short-term evaluation of adverse events by comparison of vital signs before and after administration of 68GaHTK03149 Eighteen to seventy-two hours after 68GaHTK03149 administration the participant will return to the imaging department to perform a follow up safety assessment and routine blood draw The study coordinator will ask the participant if they have experienced any adverse events during that time period and complete the adverse event questionnaire
Follow-up Assessments
The following information will be collected up to 12 months following the PETCT scans
Initiation of a new treatment Laboratory results and pathology reports Results of imaging studies Final clinical diagnosis by physician and relevant clinical notes The study is expected to take up to 1 year for accrual
After providing informed written consent subjects will complete a medical history questionnaire
Monitoring of adverse events There will be short-term evaluation of adverse events by comparison of vital signs before and after administration of 68GaHTK03149 Eighteen to seventy-two hours after 68GaHTK03149 administration the participant will return to the imaging department to perform a follow up safety assessment and routine blood draw The study coordinator will ask the participant if they have experienced any adverse events during that time period and complete the adverse event questionnaire
Follow-up Assessments
The following information will be collected up to 12 months following the PETCT scans
Initiation of a new treatment Laboratory results and pathology reports Results of imaging studies Final clinical diagnosis by physician and relevant clinical notes The study is expected to take up to 1 year for accrual
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None