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| ID | Type | Description | Link |
|---|---|---|---|
| PROS0093 | Other Identifier | OnCore | |
| IRB-48213 | Other Identifier | Stanford IRB |
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| Name | Class |
|---|---|
| General Electric | INDUSTRY |
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This study is being conducted to determine whether the combination of imaging agents 68-Ga RM2 and 68-Ga PMSA11 is better at assessing response to high intensity focused ultrasound (HIFU) or high dose rate (HDR) local therapy than standard imaging or biopsy in patients with known prostate cancer.
Primary Objective: To determine feasibility of 68Ga-PSMA-11 PET/MRI and 68Ga-RM2 PET/MRI for evaluation of HIFU or HDR local therapy in patients with known prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68-Ga RM2+68-Ga PSMA11 | Experimental | 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 PSMA11+68-Ga RM2 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68-Ga RM2 | Drug | Radioactive agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants for Which an Assessment of PET Based Therapeutic Response to HIFU is Successfully Obtained | Positron emission tomography (PET) based of Assessment of Local Therapeutic Response. Therapeutic response to HIFU will be assessed by 68-Ga PSMA 11 and 68-Ga RM2 PET scans. | Up to approximately 2 hours to complete each scan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrei H Iagaru, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36328488 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 68-Ga PSMA11+68-Ga RM2 | 68-Ga PSMA11 first followed by 68-Ga RM2 within 2 weeks, then receive high-intensity focused ultrasound (HIFU). Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11 |
| FG001 | 68-Ga RM2+68-Ga PSMA11 | 68-Ga RM2 first followed by 68-Ga PSMA11 within 2 weeks, then receive HIFU. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-HIFU Period, Imaging Timepoint 1 |
| |||||||||||||
| Pre-HIFU Period, Imaging Timepoint 2 |
| |||||||||||||
| HIFU Treatment |
| |||||||||||||
| Post-HIFU Period, Imaging Timepoint 1 |
| |||||||||||||
| Post-HIFU Period, Imaging Timepoint 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 68-Ga RM2+68-Ga PSMA11 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants for Which an Assessment of PET Based Therapeutic Response to HIFU is Successfully Obtained | Positron emission tomography (PET) based of Assessment of Local Therapeutic Response. Therapeutic response to HIFU will be assessed by 68-Ga PSMA 11 and 68-Ga RM2 PET scans. | Posted | Count of Participants | Participants | Up to approximately 2 hours to complete each scan |
|
4 weeks, plus safety follow up at up to 72 hours after the final scan
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 68-Ga PSMA11 | 68-Ga PSMA11 scan before and after HIFU | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrei Iagaru, MD | Stanford University | 650-725-4711 | aiagaru@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 4, 2022 | Jan 25, 2024 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C582579 | BAY 86-7548 |
| C000718244 | gallium 68 PSMA-11 |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| 68-Ga PSMA11 | Drug | Radioactive agent |
|
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| Investigational software and coils in PET/MR Scan | Device | Investigational software and coils in PET/MR Scan by General Electric Healthcare |
|
| PET/MRI | Procedure | Positron emission tomography (PET)/Magnetic resonance imaging (MRI) Scan |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | 68-Ga RM2 | 68-Ga RM2 scan before and after HIFU | 0 | 14 | 0 | 14 | 0 | 14 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |