68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer
NCT ID: NCT03809078
Last Updated: 2024-01-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
14 participants
INTERVENTIONAL
2019-01-14
2022-03-08
Brief Summary
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Detailed Description
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Exploratory Objective:
* Correlation of 68Ga PSMA 11 uptake and Gleason score at biopsy
* Correlation of 68Ga RM2 and Gleason score at biopsy
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
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68Ga RM2 first followed by 68Ga PSMA11
Participant will be injected IV with 140 ±20% mBq of 68Ga RM2 and then within two weeks Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11
68Ga RM2
PET radiopharmaceutical
68Ga-PSMA-11
PET radiopharmaceutical
Investigational PET scanner coils and software
GE Healthcare non-approved PET scanner coils and software
68Ga PSMA11 first followed by 68Ga RM2
Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 and then within two weeks Participant will be injected IV with 140 ±20% mBq of 68Ga RM2
68Ga RM2
PET radiopharmaceutical
68Ga-PSMA-11
PET radiopharmaceutical
Investigational PET scanner coils and software
GE Healthcare non-approved PET scanner coils and software
Interventions
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68Ga RM2
PET radiopharmaceutical
68Ga-PSMA-11
PET radiopharmaceutical
Investigational PET scanner coils and software
GE Healthcare non-approved PET scanner coils and software
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Planned prostate biopsy
* Able to provide written consent
* Karnofsky performance status of 50 (or ECOG/WHO equivalent)
Exclusion Criteria
* Metallic implants (contraindicated for MRI)
18 Years
ALL
No
Sponsors
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General Electric
INDUSTRY
Andrei Iagaru
OTHER
Responsible Party
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Andrei Iagaru
Professor of Radiology (Nuclear Medicine)
Principal Investigators
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Andrei H Iagaru, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University
Stanford, California, United States
Countries
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References
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Duan H, Ghanouni P, Daniel B, Rosenberg J, Thong A, Kunder C, Aparici CM, Davidzon GA, Moradi F, Sonn GA, Iagaru A. A Pilot Study of 68Ga-PSMA11 and 68Ga-RM2 PET/MRI for Biopsy Guidance in Patients with Suspected Prostate Cancer. J Nucl Med. 2023 May;64(5):744-750. doi: 10.2967/jnumed.122.264448. Epub 2022 Nov 17.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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PROS0091
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-48151
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2019-00236
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-48151
Identifier Type: -
Identifier Source: org_study_id
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