Expanded Access 68Gallium-PSMA-11 PET for Prostate Cancer

NCT ID: NCT04377152

Last Updated: 2021-03-01

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

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

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This expanded access protocol provides eligible participants with investigational 68Ga-PSMA-11 PET imaging to detect and localize prostate cancer for initial and subsequent treatment strategy.

Detailed Description

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Conditions

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Prostate Cancer Prostate Prostate Adenocarcinoma

Interventions

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68Gallium-PSMA-11

PSMA-11 Ga 68 Injection is a positron emitting radiopharmaceutical containing radioactive 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC (PSMA-11), which is used for diagnostic purposes in conjunction with Positron Emission Tomography (PET).

Intervention Type DRUG

Positron Emission Tomography (PET)

A PET scan is an imaging test that helps reveal how your tissues and organs are functioning using a radioactive drug (tracer) to show this activity

Intervention Type PROCEDURE

Other Intervention Names

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PSMA-HBED-CC PET PET Scan

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years
2. Histopathologically confirmed or biopsy proven prostate adenocarcinoma.
3. Concern for metastatic disease in one of the following settings:

1. Initial staging with intermediate to high risk prostate cancer.
2. Biochemical recurrence after initial therapy.
4. Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria

1\. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Thomas Hope

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Hope, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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20-30046

Identifier Type: OTHER

Identifier Source: secondary_id

EA-HOPE20200129

Identifier Type: -

Identifier Source: org_study_id

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