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

Sponsor
Mayo Clinic (Other)
Overall Status
No longer available
CT.gov ID
NCT04800068
Collaborator
(none)
1
Location

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: [Ga-68] PSMA-11 PET/CT
  • Diagnostic Test: [Ga-68] PSMA-11 PET/MR

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.

Study Design

Study Type:
Expanded Access
Official Title:
Expanded Access [Ga-68] PSMA-11 PET Imaging

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Geoffrey Johnson, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT04800068
    Other Study ID Numbers:
    • 20-013358
    First Posted:
    Mar 16, 2021
    Last Update Posted:
    Jan 21, 2022
    Last Verified:
    Jan 1, 2022
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Jan 21, 2022