Trial Outcomes & Findings for 68Ga-RM2 PET/MRI in Biochemically Recurrent Prostate Cancer (NCT NCT02624518)

Last Updated: 2023-04-10

Results Overview

Diagnostic performance of 68Ga-RM2 as a contrast imaging label will be assessed by magnetic resonance imaging (MRI) alone, or as a combined scan with positron emission tomography (PET, collectively PET/MRI). The outcome is reported as the number of tumor lesions detected with MRI alone, or with the combination PET/MRI scan, a number without dispersion.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

122 participants

Primary outcome timeframe

1 day

Results posted on

2023-04-10

Participant Flow

Participant milestones

Participant milestones
Measure	Diagnostic (68Ga-RM2 PET/MRI) Patients receive 68Ga-RM2 IV and beginning 45 minutes later undergoing PET/MRI scan. The 68Ga-RM2 PET/MRI may be repeated at the completion of treatment to evaluate response to therapy, if requested by the treating physician. Imaging with PET/MRI is the intervention. 68Ga-RM2: Imaging with PET/MRI Magnetic Resonance Imaging: Imaging with 68Ga-RM2 PET/MRI Positron Emission Tomography: Imaging with 68Ga-RM2 PET/MRI
Overall Study STARTED	122
Overall Study COMPLETED	121
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Diagnostic (68Ga-RM2 PET/MRI) Patients receive 68Ga-RM2 IV and beginning 45 minutes later undergoing PET/MRI scan. The 68Ga-RM2 PET/MRI may be repeated at the completion of treatment to evaluate response to therapy, if requested by the treating physician. Imaging with PET/MRI is the intervention. 68Ga-RM2: Imaging with PET/MRI Magnetic Resonance Imaging: Imaging with 68Ga-RM2 PET/MRI Positron Emission Tomography: Imaging with 68Ga-RM2 PET/MRI
Overall Study Physician Decision	1

Baseline Characteristics

68Ga-RM2 PET/MRI in Biochemically Recurrent Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic (68Ga-RM2 PET/MRI) n=122 Participants Patients receive 68Ga-RM2 IV and beginning 45 minutes later undergoing PET/MRI scan. The 68Ga-RM2 PET/MRI may be repeated at the completion of treatment to evaluate response to therapy, if requested by the treating physician. Imaging with PET/MRI is the intervention. 68Ga-RM2: Imaging with PET/MRI Magnetic Resonance Imaging: Imaging with 68Ga-RM2 PET/MRI Positron Emission Tomography: Imaging with 68Ga-RM2 PET/MRI
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants
Age, Categorical >=65 years	85 Participants n=5 Participants
Age, Continuous	68.4 years STANDARD_DEVIATION 6.7 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	122 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	113 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	14 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	98 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Region of Enrollment United States	122 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Outcome measures

Outcome measures
Measure	Diagnostic (68Ga-RM2 PET/MRI) n=121 Participants Patients receive 68Ga-RM2 IV and beginning 45 minutes later undergoing PET/MRI scan. The 68Ga-RM2 PET/MRI may be repeated at the completion of treatment to evaluate response to therapy, if requested by the treating physician. Imaging with PET/MRI is the intervention. 68Ga-RM2: Imaging with PET/MRI Magnetic Resonance Imaging: Imaging with 68Ga-RM2 PET/MRI Positron Emission Tomography: Imaging with 68Ga-RM2 PET/MRI
Number of Tumor Lesions Detected by 68Ga-RM2 MRI vs 68Ga-RM2 PET/MRI MRI scan	92 number of tumor lesions
Number of Tumor Lesions Detected by 68Ga-RM2 MRI vs 68Ga-RM2 PET/MRI PET/MRI scan	127 number of tumor lesions

PRIMARY outcome

Timeframe: 1 day

Sensitivity is the ability of a test to correctly identify patients who have the prostate cancer, ie, how well 68Ga-RM2 MRI vs 68Ga-RM2 PET/MRI correctly detects patients who truly have prostate cancer. Sensitivity is defined as \[TP/(TP+FN)\], where TP=true-positive, and FN=false-negative. The outcome is a percentage number with 95% confidence interval (95% CI). A higher % value means a greater probability that an imaging target identified as cancerous is confirmed by histology to be cancerous, and a lower % means reduced confidence in that result.

Outcome measures

Outcome measures
Measure	Diagnostic (68Ga-RM2 PET/MRI) n=121 Participants Patients receive 68Ga-RM2 IV and beginning 45 minutes later undergoing PET/MRI scan. The 68Ga-RM2 PET/MRI may be repeated at the completion of treatment to evaluate response to therapy, if requested by the treating physician. Imaging with PET/MRI is the intervention. 68Ga-RM2: Imaging with PET/MRI Magnetic Resonance Imaging: Imaging with 68Ga-RM2 PET/MRI Positron Emission Tomography: Imaging with 68Ga-RM2 PET/MRI
Sensitivity of MRI Alone vs PET/MRI MRI scan	48.2 percentage Interval 37.3 to 59.3
Sensitivity of MRI Alone vs PET/MRI PET/MRI scan	91.8 percentage Interval 83.8 to 96.6

PRIMARY outcome

Timeframe: 1 day

Specificity is the ability of a test to correctly identify patients who do not have the prostate cancer, ie, how well 68Ga-RM2 MRI vs 68Ga-RM2 PET/MRI correctly detects patients who do not have prostate cancer (does not falsely return a positive result). Specificity is defined as \[TN/(TN+FP)\], where TN=true-negative, and FP=false-positive. The outcome is a percentage number with 95% confidence interval (95% CI). A higher % value means a greater probability that an imaging target identified as non-cancerous is confirmed by histology to be non-cancerous, and a lower % means reduced confidence in that result.

Outcome measures

Outcome measures
Measure	Diagnostic (68Ga-RM2 PET/MRI) n=121 Participants Patients receive 68Ga-RM2 IV and beginning 45 minutes later undergoing PET/MRI scan. The 68Ga-RM2 PET/MRI may be repeated at the completion of treatment to evaluate response to therapy, if requested by the treating physician. Imaging with PET/MRI is the intervention. 68Ga-RM2: Imaging with PET/MRI Magnetic Resonance Imaging: Imaging with 68Ga-RM2 PET/MRI Positron Emission Tomography: Imaging with 68Ga-RM2 PET/MRI
Specificity of MR Alone vs PET/MRI MRI alone	97.2 percentage of participants Interval 66.1 to 99.8
Specificity of MR Alone vs PET/MRI PET/MRI scan	88.9 percentage of participants Interval 73.9 to 96.9

Adverse Events

Diagnostic (68Ga-RM2 PET/MRI)

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

David G Marcellus

Stanford Medicine at Stanford University

Phone: 650-723-4547

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place