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| ID | Type | Description | Link |
|---|---|---|---|
| PROS0091 | Other Identifier | OnCore | |
| IRB-48151 | Other Identifier | Stanford IRB | |
| NCI-2019-00236 | Other Identifier | CTRP |
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| Name | Class |
|---|---|
| General Electric | INDUSTRY |
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The objective of the study is to evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.
Primary Objective: To evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.
Exploratory Objective:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga RM2 first followed by 68Ga PSMA11 | Experimental | 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 PSMA11 first followed by 68Ga RM2 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga RM2 | Drug | PET radiopharmaceutical |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Biopsy Results Correlated With PET Based Imaging Findings | Measure of PET based Biopsy Guidance (ie, prostate uptake on 68Ga PSMA 11 and 68Ga RM2 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 |
|---|---|---|---|
| 36396456 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Scan |
| |||||||||||||
| Second Scan |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 68Ga RM2 First Followed by 68Ga 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 With Biopsy Results Correlated With PET Based Imaging Findings | Measure of PET based Biopsy Guidance (ie, prostate uptake on 68Ga PSMA 11 and 68Ga RM2 scans). | Participants who completed both scans and who had biopsy done are included in the analysis. | Posted | Count of Participants | Participants | Up to approximately 2 hours to complete each scan |
|
2 weeks, plus safety follow up at to 72 hours after the final scan
One participant discontinued the study prior to receiving the scan using 68Ga RM2.
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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 | 68Ga PSMA11 | 68Ga PSMA11 scan prior to biopsy | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrei Iagaru, MD | Stanford University | 650-725-4711 | aiagaru@stanford.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 15, 2021 | Jan 5, 2024 | Prot_001.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 |
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| 68Ga-PSMA-11 | Drug | PET radiopharmaceutical |
|
|
| Investigational PET scanner coils and software | Device | GE Healthcare non-approved PET scanner coils and software |
|
| NOT COMPLETED |
|
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. |
| 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 | 68Ga RM2 | 68Ga RM2 scan prior to biopsy | 0 | 13 | 0 | 13 | 0 | 13 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |