Trial Outcomes & Findings for Gallium Ga 68 DOTA-NeoBOMB1 and Gallium Ga 68 PSMA-R2 PET/MRI in Diagnosing Participants With Recurrent Prostate Cancer (NCT NCT03698370)
NCT ID: NCT03698370
Last Updated: 2024-01-30
Results Overview
The number of lesions detected on Ga- NeoBOMB1 positron emission tomography (PET)/magnetic resonance imaging (MRI), Ga PSMA R2 PET/MRI, and conventional MR will be compared.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Up to approximately 2 hours to complete each scan
Results posted on
2024-01-30
Participant Flow
Participant milestones
| Measure |
Ga68-NeoBOMB1 Then Ga68 PSMA-R2
Participants receive gallium Ga 68 DOTA-NeoBOMB1 IV and 45 minutes later, undergo PET/MRI. Within 2 weeks, participants receive gallium Ga 68 PSMA-R2 IV then undergo PET/MRI 45-60 minutes later.
|
Ga68 PSMA-R2 Then Ga 68-NeoBOMB1)
Participants receive gallium Ga 68 PSMA-R2 IV and 45-60 minutes later undergo PET/MRI. Within 2 weeks, participants receive gallium Ga 68 DOTA-NeoBOMB1 IV then undergo PET/MRI 45 minutes later.
|
|---|---|---|
|
First Scan
STARTED
|
13
|
14
|
|
First Scan
COMPLETED
|
13
|
14
|
|
First Scan
NOT COMPLETED
|
0
|
0
|
|
Second Scan
STARTED
|
13
|
14
|
|
Second Scan
COMPLETED
|
13
|
14
|
|
Second Scan
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gallium Ga 68 DOTA-NeoBOMB1 and Gallium Ga 68 PSMA-R2 PET/MRI in Diagnosing Participants With Recurrent Prostate Cancer
Baseline characteristics by cohort
| Measure |
Ga68-NeoBOMB1 Then Ga68 PSMA-R2
n=13 Participants
Participants receive gallium Ga 68 DOTA-NeoBOMB1 IV and 45 minutes later, undergo PET/MRI. Within 2 weeks, participants receive gallium Ga 68 PSMA-R2 IV then undergo PET/MRI 45-60 minutes later.
|
Ga68 PSMA-R2 Then Ga 68-NeoBOMB1)
n=14 Participants
Participants receive gallium Ga 68 PSMA-R2 IV and 45-60 minutes later undergo PET/MRI. Within 2 weeks, participants receive gallium Ga 68 DOTA-NeoBOMB1 IV then undergo PET/MRI 45 minutes later.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
67.9 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
67.8 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 2 hours to complete each scanThe number of lesions detected on Ga- NeoBOMB1 positron emission tomography (PET)/magnetic resonance imaging (MRI), Ga PSMA R2 PET/MRI, and conventional MR will be compared.
Outcome measures
| Measure |
Ga68-NeoBOMB1
n=27 Participants
Participants receive gallium Ga 68 DOTA-NeoBOMB1.
|
Ga68 PSMA-R2
n=27 Participants
Participants receive gallium Ga 68 PSMA-R2.
|
|---|---|---|
|
Number of Lesions Detected by Investigational Imaging Agent
|
31 lesions
|
20 lesions
|
SECONDARY outcome
Timeframe: At 1 year post-scan follow-upThe predictive value of Ga- NeoBOMB1 PET/MRI and Ga PSMA R2 PET/MRI imaging will be evaluated based on biopsy and/or imaging results at the end of the 12 month standard clinical follow-up period, by comparing the investigational scans against scans the patient received as standard of care.
Outcome measures
| Measure |
Ga68-NeoBOMB1
n=31 lesions
Participants receive gallium Ga 68 DOTA-NeoBOMB1.
|
Ga68 PSMA-R2
n=20 lesions
Participants receive gallium Ga 68 PSMA-R2.
|
|---|---|---|
|
Number of Detected Lesions Confirmed to be Malignant for Each Imaging Method
|
18 lesions
|
15 lesions
|
Adverse Events
Ga68-NeoBOMB1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ga68 PSMA-R2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place