A Phase 2 interventional study of 68Ga RM2 and 68Ga-PSMA-11 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 2024-01-11.
Sponsored by Andrei Iagaru · Phase 2, Interventional, and Diagnostic
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:
Exclusion Criteria:
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
Drug: 68Ga RM2 · Drug: 68Ga-PSMA-11 · Device: Investigational PET scanner coils and software
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
Drug: 68Ga RM2 · Drug: 68Ga-PSMA-11 · Device: Investigational PET scanner coils and software
PET radiopharmaceutical
Also known as: 68Ga DOTA Bombesin, BAY86 7548
PET radiopharmaceutical
Also known as: DFKZ 11, HBED CC PSMA, Heidelberg compound
GE Healthcare non-approved PET scanner coils and software
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).
Time frame: Up to approximately 2 hours to complete each scan
| Milestone | 68Ga PSMA11 First Followed by 68Ga RM2 | 68Ga RM2 First Followed by 68Ga PSMA11 |
|---|---|---|
| Started | 7 | 7 |
| Completed | 7 | 7 |
| Not completed | 0 | 0 |
| Milestone | 68Ga PSMA11 First Followed by 68Ga RM2 | 68Ga RM2 First Followed by 68Ga PSMA11 |
|---|---|---|
| Started | 6 | 7 |
| Completed | 6 | 7 |
| Not completed | 0 | 0 |
Measure of PET based Biopsy Guidance (ie, prostate uptake on 68Ga PSMA 11 and 68Ga RM2 scans).
| Participants | 68Ga PSMA11 | 68Ga RM2 |
|---|---|---|
| Number of Participants With Biopsy Results Correlated With PET Based Imaging Findings | 13 | 13 |
Collected over 2 weeks, plus safety follow up at to 72 hours after the final scan. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 68Ga PSMA11 | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| 68Ga RM2 | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Age, Continuous(years) | 68Ga PSMA11 First Followed by 68Ga RM2 | 68Ga RM2 First Followed by 68Ga PSMA11 | Total |
|---|---|---|---|
| Mean | 63.4 ± 4.4 | 55.7 ± 7.3 | 59.6 ± 7.2 |
| Sex: Female, Male(Participants) | 68Ga PSMA11 First Followed by 68Ga RM2 | 68Ga RM2 First Followed by 68Ga PSMA11 | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 7 | 7 | 14 |
| Ethnicity (NIH/OMB)(Participants) | 68Ga PSMA11 First Followed by 68Ga RM2 | 68Ga RM2 First Followed by 68Ga 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) | 68Ga PSMA11 First Followed by 68Ga RM2 | 68Ga RM2 First Followed by 68Ga PSMA11 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 2 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 3 | 5 | 8 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | 68Ga PSMA11 First Followed by 68Ga RM2 | 68Ga RM2 First Followed by 68Ga PSMA11 | Total |
|---|---|---|---|
| United States | 7 | 7 | 14 |
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Andrei Iagaru