68Ga-PSMA-11 PET for the Diagnosis of Biochemically Recurrent Prostate Cancer
NCT ID: NCT04216134
Last Updated: 2023-06-15
Study Results
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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COMPLETED
PHASE1
19 participants
INTERVENTIONAL
2019-12-12
2022-12-09
Brief Summary
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Detailed Description
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I. To provide clinical access to and assess the safety of the investigational agent Gallium Ga 68-labeled prostate specific membrane antigen (PSMA)-11 (68Ga-PSMA-11) positron emission tomography (PET) at City of Hope National Medical Center for patients co-enrolled on Institutional Review Board (IRB) 18517 treatment trial.
OUTLINE:
Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over less than 1 minute, and then undergo PET over 60 minutes.
After completion of study, patients are followed up at 1-3 days, and then at 3 weeks.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (68GA-PSMA-11 PET)
Patients receive gallium Ga 68-labeled PSMA-11 IV over less than 1 minute, and then undergo PET over 60 minutes.
Gallium Ga 68-labeled PSMA-11
Given IV
Positron Emission Tomography
Undergo 68GA-PSMA-11 PET
Interventions
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Gallium Ga 68-labeled PSMA-11
Given IV
Positron Emission Tomography
Undergo 68GA-PSMA-11 PET
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Karnofsky performance status of \>= 50
* The effects of 68Ga-PSMA-11 on the developing fetus are unknown. For this reason, subjects must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation when having sex with a pregnant female or with a female partner of childbearing potential
* Co-enrollment on IRB 18517
* Documented informed consent of the patient. All subjects must have the ability to understand and the willingness to sign a written informed consent
Exclusion Criteria
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga-PSMA-11
* Use of another concomitant investigational therapy (with the exception of the investigational treatment given in IRB 18517) for prostate cancer within 7 days of scheduled 68Ga-PSMA-11 PET scan
* Unable to tolerate PET scan (i.e. if the patient is claustrophobic or unable to lie still for 30-60 minutes)
* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Maria Parayno
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Other Identifiers
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NCI-2019-08625
Identifier Type: REGISTRY
Identifier Source: secondary_id
19517
Identifier Type: OTHER
Identifier Source: secondary_id
19517
Identifier Type: -
Identifier Source: org_study_id
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