Prostate CancerPhase 1/2NCT03949517
68-Ga PSMA 11 PET/MRI and 68-Ga RM2 PET/MRI for Evaluation of Prostate Cancer Response to HIFU Therapy
A Phase 1/2 study testing 68-Ga RM2, 68-Ga PSMA11 and Investigational software and coils in PET/MR Scan in people with Prostate Cancer, run by Andrei Iagaru at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 68-Ga RM2, 68-Ga PSMA11 and Investigational software and coils in PET/MR Scan
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2019to 7 Mar 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Known prostate cancer
- 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)
Who cannot join
- Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
- Metallic implants (contraindicated for MRI)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Evaluation of Prostate Cancer Response to HIFU Therapy
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.
Read the detailed description
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.
- Conditions
- Prostate Cancer
- Being tested
- 68-Ga RM2, 68-Ga PSMA11, Investigational software and coils in PET/MR Scan, PET/MRI
- Keywords
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68-Ga RM2Drug
Also called 68Ga-DOTA-4-amino-1-carboxymethyl-piperidine-DPhe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2, 68Ga-DOTA-Bombesin, BAY86-7548
Radioactive agent
68-Ga PSMA11Drug
Also called DFKZ 11, HBED CC PSMA, Heidelberg compound
Radioactive agent
Investigational software and coils in PET/MR ScanDevice
Investigational software and coils in PET/MR Scan by General Electric Healthcare
PET/MRIProcedure or surgery
Also called Positron emission tomography (PET)/Magnetic resonance imaging (MRI)
Positron emission tomography (PET)/Magnetic resonance imaging (MRI) Scan
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: 68-Ga RM2; Drug: 68-Ga PSMA11; Device: Investigational software and coils in PET/MR Scan; Procedure: PET/MRI |
| 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 Receives: Drug: 68-Ga RM2; Drug: 68-Ga PSMA11; Device: Investigational software and coils in PET/MR Scan; Procedure: PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 2 hours to complete each scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start9 Apr 2019
- Primary completion7 Mar 2022
- Study completion7 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrei Iagaru
- Sponsor type
- University, hospital or other
- Collaborators
- General Electric
- Responsible party
- Sponsor-investigator, Andrei Iagaru, Stanford University
- Investigators
- Andrei H Iagaru, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949517
- Sponsor's protocol ID
- IRB-48213
- Other IDs
- PROS0093, IRB-48213
- Status last verified
- Jan 2024
- First submitted
- 10 May 2019
- Last updated
- 30 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 36328488
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Evaluation of Prostate Cancer Response to HIFU Therapy
- ClinicalTrials.gov ID
- NCT03949517
- Acronym / sponsor ID
- IRB-48213
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Andrei IagaruUniversity, hospital or other
- Collaborators
- General Electric
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 7 Mar 2022 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Posted 30 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 68-Ga RM2+68-Ga PSMA11 | Experimental | Drug: 68-Ga RM2, Drug: 68-Ga PSMA11, Device: Investigational software and coils in PET/MR Scan, Procedure: PET/MRI68-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 | Drug: 68-Ga RM2, Drug: 68-Ga PSMA11, Device: Investigational software and coils in PET/MR Scan, Procedure: PET/MRI68-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Known prostate cancer
- 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)
Key exclusion criteria (2 listed)
- Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
- Metallic implants (contraindicated for MRI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68-Ga RM2Also: 68Ga-DOTA-4-amino-1-carboxymethyl-piperidine-DPhe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2, 68Ga-DOTA-Bombesin, BAY86-7548Radioactive agent | Drug | 68-Ga PSMA11+68-Ga RM2, 68-Ga RM2+68-Ga PSMA11 |
| 68-Ga PSMA11Also: DFKZ 11, HBED CC PSMA, Heidelberg compoundRadioactive agent | Drug | 68-Ga PSMA11+68-Ga RM2, 68-Ga RM2+68-Ga PSMA11 |
| Investigational software and coils in PET/MR ScanInvestigational software and coils in PET/MR Scan by General Electric Healthcare | Device | 68-Ga PSMA11+68-Ga RM2, 68-Ga RM2+68-Ga PSMA11 |
| PET/MRIAlso: Positron emission tomography (PET)/Magnetic resonance imaging (MRI)Positron emission tomography (PET)/Magnetic resonance imaging (MRI) Scan | Procedure or surgery | 68-Ga PSMA11+68-Ga RM2, 68-Ga RM2+68-Ga PSMA11 |
Primary outcome
Number of Participants for Which an Assessment of PET Based Therapeutic Response to HIFU is Successfully Obtained
Time frame: Up to approximately 2 hours to complete each scan
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36328488Duan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrei H Iagaru, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 68-Ga RM2, 68-Ga PSMA11 and Investigational software and coils in PET/MR Scan in people with Prostate Cancer, run by Andrei Iagaru at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants for Which an Assessment of PET Based Therapeutic Response to HIFU is Successfully Obtained (time frame: Up to approximately 2 hours to complete each scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03949517, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.