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Expanded Access [Ga-68] PSMA-11 PET Imaging

Expanded Access [Ga-68] PSMA-11 PET Imaging

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT04800068
Enrollment
Unknown
Registered
2021-03-16
Start date
Unknown
Completion date
Unknown
Last updated
2022-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Interventions

DIAGNOSTIC_TEST[Ga-68] PSMA-11 PET/CT

Imaging scan

DIAGNOSTIC_TEST[Ga-68] PSMA-11 PET/MR

Imaging scan

Sponsors

Mayo Clinic
Lead SponsorOTHER

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum

Inclusion criteria

Participant Groups There are two participant groups; please refer to the inclusion details below: Group 1: Untreated High-Risk prostate cancer group (must meet at least one of the following inclusion criteria): 1. Serum prostate-specific antigen (PSA) concentration of 20 ng/mL or more 2. Pathologic criteria of International Society of Uropathology (ISUP) grade group 3-5 (ISUP grades 3-5 are equivalent to pathologic Gleason scores of 4+3, 8, 9 or 10) 3. Local staging of T3 or worse (Indicating that cancer has invaded into tissues outside of the prostate gland, as seen at either CT or MRI) Biochemically Recurrent prostate cancer group (must meet one of the criteria): 1. In patients who have undergone a prostatectomy, PSA \> 0.2 ng/ml on 2 consecutive tests 2. In patients who have undergone definitive prostate radiation, PSA rise ≥ 2 ng/mL above the nadir PSA

Exclusion criteria

Current

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026