Ignite Creation Date:
2024-05-06 @ 4:21 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04951817
Status:
RECRUITING
Last Update Posted:
2022-03-03
First Post:
2021-06-30
Brief Title:
68Ga-PSMA PETCT for Ra223 Assessment
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Using 68Ga-PSMA PETCT for the Assessment of Osseous Tumor Burden in mCRPC Patients Undergoing 223Ra-dichloride Injections
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
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:
Primary objective
iThe primary objective is to compare the diagnostic positivity in progression of 68Ga-PSMA PET and Bone scan
Secondary objectives
iThe correlation between PET osseous tumor burden index and Alk-P level iiThe correlation between PET osseous tumor burden index and PSA level
iThe primary objective is to compare the diagnostic positivity in progression of 68Ga-PSMA PET and Bone scan
Secondary objectives
iThe correlation between PET osseous tumor burden index and Alk-P level iiThe correlation between PET osseous tumor burden index and PSA level
Detailed Description:
It is a open-label single-arm clinical trial Outcome measurement is the positivity rate of Ga68-PSMA-11 PET-defined progression and Bone Scan-defined progression The primary objective is to compare the diagnostic positivity in progression of PSMA PET and BS The 22 contingency table with four diagnostic outcomes both positive PET positiveBS negative PET negativeBS positive and both negative will be conducted based on the enrolled subjects Both diagnostic tools Ga68-PSMA-11 PET and BS are applied to a given set of individuals Since both diagnostic tools will performed on each subject then paired data result and methods that account for the correlated binary outcomes are necessary McNemars test will be used to compare the positivity of the two tools Assuming that Ga68-PSMA-11 PET in patients detect more metastatic lesionsprogression by 265 ie p10-p010265 and the discordant percentage is 385 ie p10p010385 Under the hypothesis H0 p10p01 achieving an 80 power at the 5 of significance level the sample size is 44 Based on expecting 15 of missing rate the adjusted sample size will be 52 This calculation was done by PASS software Power Analysis and Sample Size version 1108 NCSS Kaysville Utah USA
For PETCT PSMA scan the subject will have catheters placed for intravenous administration of 68GaPSMA-11 Subjects will receive a single intravenous bolus of 2-5 mCi 68GaPSMA-11 and received PETCT scan 60 minutes later PSMA PET-CT scan was performed on a GE Discovery MI PETCT system The CT scan parameters were 120 kVp 30 mA to 300 mA acquired with auto mA 40 0625 collimator configuration and pitch of 0984 1 All images were reconstructed with a 500 mm field of view and a slice thickness of 5 mm The PET acquisition time was 3 mins per bed position with maximum overlap 35 slices Images were reconstructed using Q clear with beta value of 550 PSF correction and non-TOF QCHD-S The matrix is 256 256 After image acquisition the subject will be observed for half an hour and will be discharged if no adverse event happens EKG blood and biochemistry test will be performed before and after first PET scan no more than two weeks Except baseline Ga68-PSMA-11 PETCT scan patients will receive serial PET scans after 3rd injection of Ra-233 and 6th injection of Ra-223 All of the images were interpreted by an experienced nuclear medicine physicians
For PETCT PSMA scan the subject will have catheters placed for intravenous administration of 68GaPSMA-11 Subjects will receive a single intravenous bolus of 2-5 mCi 68GaPSMA-11 and received PETCT scan 60 minutes later PSMA PET-CT scan was performed on a GE Discovery MI PETCT system The CT scan parameters were 120 kVp 30 mA to 300 mA acquired with auto mA 40 0625 collimator configuration and pitch of 0984 1 All images were reconstructed with a 500 mm field of view and a slice thickness of 5 mm The PET acquisition time was 3 mins per bed position with maximum overlap 35 slices Images were reconstructed using Q clear with beta value of 550 PSF correction and non-TOF QCHD-S The matrix is 256 256 After image acquisition the subject will be observed for half an hour and will be discharged if no adverse event happens EKG blood and biochemistry test will be performed before and after first PET scan no more than two weeks Except baseline Ga68-PSMA-11 PETCT scan patients will receive serial PET scans after 3rd injection of Ra-233 and 6th injection of Ra-223 All of the images were interpreted by an experienced nuclear medicine physicians
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