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NCT04800068 Clinical Trial

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

Prostate Cancer Clinical Trial

Official title:
Expanded Access [Ga-68] PSMA-11 PET Imaging

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT04800068
Other study ID # 20-013358
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date January 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Male
Age group 18 Years and older
Eligibility 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 exclusion criteria for both groups includes: 1. Patients unable to sign informed consent 2. Patient with a life expectancy less than 6 months 3. Additional exclusion criteria may be added based on demand

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• [Ga-68] PSMA-11 PET/CT
Imaging scan
• [Ga-68] PSMA-11 PET/MR
Imaging scan

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

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