A Phase 1/2 interventional study of 68-Ga RM2 and 68-Ga PSMA11 in Prostate Cancer, sponsored by Andrei Iagaru. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Andrei Iagaru · Phase 1/2, Interventional, and Treatment
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 14 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Andrei Iagaru is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 12 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Studies often ask for 60 or 70 and above. Your doctor gives the score.
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Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
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Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: 68-Ga RM2 · Drug: 68-Ga PSMA11 · Device: Investigational software and coils in PET/MR Scan · Procedure: PET/MRI
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
Drug: 68-Ga RM2 · Drug: 68-Ga PSMA11 · Device: Investigational software and coils in PET/MR Scan · Procedure: PET/MRI
Radioactive agent
Also known as: 68Ga-DOTA-4-amino-1-carboxymethyl-piperidine-DPhe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2, 68Ga-DOTA-Bombesin, BAY86-7548
Radioactive agent
Also known as: DFKZ 11, HBED CC PSMA, Heidelberg compound
Investigational software and coils in PET/MR Scan by General Electric Healthcare
Positron emission tomography (PET)/Magnetic resonance imaging (MRI) Scan
Also known as: Positron emission tomography (PET)/Magnetic resonance imaging (MRI)
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.
Time frame: Up to approximately 2 hours to complete each scan
| Milestone | 68-Ga PSMA11+68-Ga RM2 | 68-Ga RM2+68-Ga PSMA11 |
|---|---|---|
| Started | 7 | 7 |
| Completed | 7 | 7 |
| Not completed | 0 | 0 |
| Milestone | 68-Ga PSMA11+68-Ga RM2 | 68-Ga RM2+68-Ga PSMA11 |
|---|---|---|
| Started | 7 | 7 |
| Completed | 7 | 7 |
| Not completed | 0 | 0 |
| Milestone | 68-Ga PSMA11+68-Ga RM2 | 68-Ga RM2+68-Ga PSMA11 |
|---|---|---|
| Started | 7 | 7 |
| Completed | 7 | 7 |
| Not completed | 0 | 0 |
| Milestone | 68-Ga PSMA11+68-Ga RM2 | 68-Ga RM2+68-Ga PSMA11 |
|---|---|---|
| Started | 7 | 7 |
| Completed | 7 | 7 |
| Not completed | 0 | 0 |
| Milestone | 68-Ga PSMA11+68-Ga RM2 | 68-Ga RM2+68-Ga PSMA11 |
|---|---|---|
| Started | 7 | 7 |
| Completed | 7 | 7 |
| Not completed | 0 | 0 |
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.
| Participants | 68-Ga PSMA11 | 68-Ga RM2 |
|---|---|---|
| Number of Participants for Which an Assessment of PET Based Therapeutic Response to HIFU is Successfully Obtained | 14 | 14 |
Collected over 4 weeks, plus safety follow up at up to 72 hours after the final scan. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 68-Ga PSMA11 | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| 68-Ga RM2 | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Age, Continuous(years) | 68-Ga PSMA11+68-Ga RM2 | 68-Ga RM2+68-Ga PSMA11 | Total |
|---|---|---|---|
| Mean | 67.5 ± 7.5 | 63.9 ± 8.1 | 64.5 ± 8.0 |
| Sex: Female, Male(Participants) | 68-Ga PSMA11+68-Ga RM2 | 68-Ga RM2+68-Ga PSMA11 | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 7 | 7 | 14 |
| Ethnicity (NIH/OMB)(Participants) | 68-Ga PSMA11+68-Ga RM2 | 68-Ga RM2+68-Ga PSMA11 | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 7 | 7 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 68-Ga PSMA11+68-Ga RM2 | 68-Ga RM2+68-Ga PSMA11 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 7 | 5 | 12 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | 68-Ga PSMA11+68-Ga RM2 | 68-Ga RM2+68-Ga PSMA11 | Total |
|---|---|---|---|
| United States | 7 | 7 | 14 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2019 to primary completion in Mar 2022, 34 months.
Results were first posted in Jan 2024, 1 year 10 months after primary completion.
Of 114 non-industry phase 1/2 interventional studies under Prostatic Neoplasms, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 85. This study's 34 months is below that.
Counting every sponsor, half of 210 studies reached it within 61 months; a quarter within 30 and three quarters within 85.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Rm-2 ga-68 · Gallium 68 PSMA-11
Andrei Iagaru