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

NCT ID: NCT04800068

Last Updated: 2022-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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\[Ga-68\] 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.

Conditions

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Prostate Cancer

Interventions

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[Ga-68] PSMA-11 PET/CT

Imaging scan

Intervention Type DIAGNOSTIC_TEST

[Ga-68] PSMA-11 PET/MR

Imaging scan

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

1. Patients unable to sign informed consent
2. Patient with a life expectancy less than 6 months
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Geoffrey Johnson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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20-013358

Identifier Type: -

Identifier Source: org_study_id

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