Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04800068
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2022-01-21
First Post:
2021-03-12
Brief Title:
Expanded Access Ga-68 PSMA-11 PET Imaging
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Expanded Access Ga-68 PSMA-11 PET Imaging
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2022-01
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:
In this expanded access IND study Mayo Clinic in Rochester MN offers Ga-68 PSMA-11 PETCT or PETMR imaging to patients who meet criteria
Detailed Description:
Ga-68 PSMA-11 PETCT and PETMR imaging has been shown to allow for accurate detection of metastatic prostate cancer at the time of initial diagnosis and staging of patients with high-risk prostate cancer and at the time of biochemical recurrence In addition available data show superiority of metastatic lesion detection with Ga-68 PSMA-11 PET over conventional imaging This improved lesion detection has a direct impact on selection of anti-cancer therapy and thus may improve patient outcomes
Under expanded access IND enrolled patients will receive a clinical 68Ga PSMA-11 PETCT or PETMR for evaluation of their cancer Imaging exams must be deemed clinically indicated by a referring provider Patients will be responsible for the cost of the imaging exam Access is limited
Under expanded access IND enrolled patients will receive a clinical 68Ga PSMA-11 PETCT or PETMR for evaluation of their cancer Imaging exams must be deemed clinically indicated by a referring provider Patients will be responsible for the cost of the imaging exam Access is limited
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