Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-30 @ 7:32 AM
Study NCT ID:
NCT04976257
Status:
COMPLETED
Last Update Posted:
2023-04-07
First Post:
2021-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion
Sponsor:
Ryan Kohlbrenner, MD
Organization:
Study Overview
Official Title:
Pharmacokinetic Comparison of Selective Prostatic Arterial and Intravenous PSMA Radioligand Infusions in Treatment-Naïve Prostate Cancer Patients
Status:
COMPLETED
Status Verified Date:
2023-04
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:
None
Brief Summary:
Prostate-specific membrane antigen (PSMA) agents have shown promise in detecting and treating prostate cancer. Gallium-68-labeled PSMA-11 (68Ga-PSMA-11) is a radioactive agent that binds to prostate cancer cells and can be imaged using positron emission tomography (PET) scanners that detect radioactivity in the body. This early phase I study will use PET to determine if delivering 68Ga-PSMA-11 directly into the prostatic artery (intra-arterial (IA) administration) results in greater uptake in the prostate than delivering 68Ga-PSMA-11 into a vein in the arm (intravenous (IV) administration).
Detailed Description:
PRIMARY OBJECTIVE:
I. To compare the maximum standardized uptake value (SUVmax) in tumoral regions-of-interest during prostatic arterial and intravenous 68Ga-PSMA-11 infusions.
SECONDARY OBJECTIVES:
I. To compare the tumoral time-activity curves for selective prostatic arterial and intravenous 68Ga-PSMA-11 infusions.
II. To study PSMA receptor saturation kinetics during selective prostatic arterial infusion of 68Ga-PSMA-11 (obtained only from arterial time activity curves \[TACs\] ipsilateral to the side of infusion).
OUTLINE:
Patients receive 68Ga-PSMA-11 IV over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after on day 1. 1-14 days later, patients undergo pelvic angiogram and prostatic arterial catheterization. Patients then receive 68Ga-PSMA-11 IA over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after.
After completion of study, patients are followed up with 24 hours after the IA infusion and PET scan.
I. To compare the maximum standardized uptake value (SUVmax) in tumoral regions-of-interest during prostatic arterial and intravenous 68Ga-PSMA-11 infusions.
SECONDARY OBJECTIVES:
I. To compare the tumoral time-activity curves for selective prostatic arterial and intravenous 68Ga-PSMA-11 infusions.
II. To study PSMA receptor saturation kinetics during selective prostatic arterial infusion of 68Ga-PSMA-11 (obtained only from arterial time activity curves \[TACs\] ipsilateral to the side of infusion).
OUTLINE:
Patients receive 68Ga-PSMA-11 IV over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after on day 1. 1-14 days later, patients undergo pelvic angiogram and prostatic arterial catheterization. Patients then receive 68Ga-PSMA-11 IA over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after.
After completion of study, patients are followed up with 24 hours after the IA infusion and PET scan.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2021-06580 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |