68-Ga PSMA 11 PET/MRI and 68-Ga RM2 PET/MRI for Evaluation of Prostate Cancer Response to HIFU Therapy
NCT ID: NCT03949517
Last Updated: 2024-01-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
14 participants
INTERVENTIONAL
2019-04-09
2022-03-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer
NCT03809078
PSMA-PET/MRI Unfavorable-Risk Target Volume Pilot Study
NCT04176497
Monitoring Patient Prostate Health Post Therapy
NCT07115914
68Ga-PSMA-11 PET/MRI in Finding Tumors in Patients With Intermediate or High-Risk Prostate Cancer Undergoing Surgery
NCT02678351
18F-PSMA PET and MRI in the Primary Staging of Prostate Cancer Patients
NCT05141760
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
68-Ga RM2+68-Ga PSMA11
68-Ga RM2 first followed by 68-Ga PSMA11 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11
68-Ga RM2
Radioactive agent
68-Ga PSMA11
Radioactive agent
Investigational software and coils in PET/MR Scan
Investigational software and coils in PET/MR Scan by General Electric Healthcare
PET/MRI
Positron emission tomography (PET)/Magnetic resonance imaging (MRI) Scan
68-Ga PSMA11+68-Ga RM2
68-Ga PSMA11 first followed by 68-Ga RM2 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11
68-Ga RM2
Radioactive agent
68-Ga PSMA11
Radioactive agent
Investigational software and coils in PET/MR Scan
Investigational software and coils in PET/MR Scan by General Electric Healthcare
PET/MRI
Positron emission tomography (PET)/Magnetic resonance imaging (MRI) Scan
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
68-Ga RM2
Radioactive agent
68-Ga PSMA11
Radioactive agent
Investigational software and coils in PET/MR Scan
Investigational software and coils in PET/MR Scan by General Electric Healthcare
PET/MRI
Positron emission tomography (PET)/Magnetic resonance imaging (MRI) Scan
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Planned HIFU or HDR local therapy
* Able to provide written consent
* Karnofsky performance status of 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent)
Exclusion Criteria
* Metallic implants (contraindicated for MRI)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
General Electric
INDUSTRY
Andrei Iagaru
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Andrei Iagaru
Professor of Radiology (Nuclear Medicine)
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrei H Iagaru, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stanford University
Stanford, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Duan H, Ghanouni P, Daniel B, Rosenberg J, Davidzon GA, Aparici CM, Kunder C, Sonn GA, Iagaru A. A Pilot Study of 68Ga-PSMA11 and 68Ga-RM2 PET/MRI for Evaluation of Prostate Cancer Response to High-Intensity Focused Ultrasound Therapy. J Nucl Med. 2023 Apr;64(4):592-597. doi: 10.2967/jnumed.122.264783. Epub 2022 Nov 3.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PROS0093
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-48213
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-48213
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.