Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-25 @ 3:58 PM
Study NCT ID:
NCT04800068
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2022-01-21
First Post:
2021-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Expanded Access [Ga-68] PSMA-11 PET Imaging
Sponsor:
Mayo Clinic
Organization:
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 PET/CT or PET/MR imaging to patients who meet criteria.
Detailed Description:
\[Ga-68\] PSMA-11 PET/CT and PET/MR 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 PET/CT or PET/MR 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 PET/CT or PET/MR 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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: