Trial Outcomes & Findings for PET Imaging of Cyclooxygenase in Multiple Sclerosis (NCT NCT05062083)
NCT ID: NCT05062083
Last Updated: 2024-06-27
Results Overview
Standard uptake value (SUV) was measured by averaging the SUV of all lesion voxels or tissue contralateral to lesion voxels in the PET image with injection of \[11C\]PS13. The SUVR was calculated by averaging the SUV ratio between lesion or tissue contralateral to lesion voxels and the caudate from 60-90 minutes after the start of the PET scan.
TERMINATED
PHASE2
7 participants
60-90 minutes after the start of PET scan
2024-06-27
Participant Flow
Of the seven participants who were consented to the study, two participants were screen failure.
Participant milestones
| Measure |
Participants With Multiple Sclerosis
Participants had two brain positron emission tomography (PET) scan visits. In one visit, participants had a baseline \[11C\]PS13 scan followed by a second \[11C\]PS13 scan after blockade with ketoprofen 75 mg orally. In another visit, participants had baseline \[11C\]MC1 scan followed by a second scan with \[11C\]MC1 after blockade by a dose of celecoxib 600 mg orally. Participants receive injection of up to 20 millicurie (mCi) of \[11C\]PS13 or \[11C\]MC1 during each scan.
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|---|---|
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Overall Study
STARTED
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5
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Overall Study
COMPLETED
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5
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PET Imaging of Cyclooxygenase in Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Participants With Multiple Sclerosis
n=5 Participants
Participants had two brain positron emission tomography (PET) scan visits. In one visit, participants had a baseline \[11C\]PS13 scan followed by a second \[11C\]PS13 scan after blockade with ketoprofen 75 mg orally. In another visit, participants had baseline \[11C\]MC1 scan followed by a second scan with \[11C\]MC1 after blockade by a dose of celecoxib 600 mg orally. Participants receive injection of up to 20 millicurie (mCi) of \[11C\]PS13 or \[11C\]MC1 during each scan.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=93 Participants
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Age, Categorical
Between 18 and 65 years
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5 Participants
n=93 Participants
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Age, Categorical
>=65 years
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0 Participants
n=93 Participants
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Sex: Female, Male
Female
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5 Participants
n=93 Participants
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Sex: Female, Male
Male
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0 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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5 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=93 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=93 Participants
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Race (NIH/OMB)
White
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5 Participants
n=93 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=93 Participants
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Region of Enrollment
United States
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5 participants
n=93 Participants
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PRIMARY outcome
Timeframe: 60-90 minutes after the start of PET scanPopulation: The analyses included only subjects who completed the study.
Standard uptake value (SUV) was measured by averaging the SUV of all lesion voxels or tissue contralateral to lesion voxels in the PET image with injection of \[11C\]PS13. The SUVR was calculated by averaging the SUV ratio between lesion or tissue contralateral to lesion voxels and the caudate from 60-90 minutes after the start of the PET scan.
Outcome measures
| Measure |
Participants With Multiple Sclerosis
n=5 Participants
Participants had two brain positron emission tomography (PET) scan visits. In one visit, participants had a baseline \[11C\]PS13 scan followed by a second \[11C\]PS13 scan after blockade with ketoprofen 75 mg orally. In another visit, participants had baseline \[11C\]MC1 scan followed by a second scan with \[11C\]MC1 after blockade by a dose of celecoxib 600 mg orally. Participants receive injection of up to 20 millicurie (mCi) of \[11C\]PS13 or \[11C\]MC1 during each scan.
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|---|---|
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Standard Uptake Value Ratio (SUVR) of Lesions With Injection of [11C]PS13
Brain lesions
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1.380 SUV Ratio (SUVR)
Standard Deviation 0.112
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Standard Uptake Value Ratio (SUVR) of Lesions With Injection of [11C]PS13
Contralateral normal appearing brain tissues
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1.408 SUV Ratio (SUVR)
Standard Deviation 0.109
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PRIMARY outcome
Timeframe: 60-90 minutes after the start of PET scanPopulation: The analyses included only subjects who completed the study.
Standard uptake value (SUV) was measured by averaging the SUV of all lesion voxels or tissue contralateral to lesion voxels in the PET image with injection of \[11C\]MC1. The SUVR was calculated by averaging the SUV ratio between lesion or tissue contralateral to lesion voxels and the cerebellum from 60-90 minutes after the start of the PET scan.
Outcome measures
| Measure |
Participants With Multiple Sclerosis
n=5 Participants
Participants had two brain positron emission tomography (PET) scan visits. In one visit, participants had a baseline \[11C\]PS13 scan followed by a second \[11C\]PS13 scan after blockade with ketoprofen 75 mg orally. In another visit, participants had baseline \[11C\]MC1 scan followed by a second scan with \[11C\]MC1 after blockade by a dose of celecoxib 600 mg orally. Participants receive injection of up to 20 millicurie (mCi) of \[11C\]PS13 or \[11C\]MC1 during each scan.
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|---|---|
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Standard Uptake Value Ratio (SUVR) of Lesions With Injection of [11C]MC1
Brain lesions
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1.455 SUV Ratio (SUVR)
Standard Deviation 0.142
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Standard Uptake Value Ratio (SUVR) of Lesions With Injection of [11C]MC1
Contralateral normal appearing brain tissues
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1.594 SUV Ratio (SUVR)
Standard Deviation 0.120
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PRIMARY outcome
Timeframe: 60-90 minutes after the start of PET scanPopulation: The analyses included only subjects who completed the study.
Calculation of standard uptake value (SUV) by averaging the SUV of all lesion voxels or tissue contralateral to lesion voxels in the PET image with injection of \[11C\]PS13 after blockade with ketoprofen. Calculation of SUVR by averaging the SUV ratio between lesion or tissue contralateral to lesion voxels and the caudate from 60-90 minutes after the start of the PET scan.
Outcome measures
| Measure |
Participants With Multiple Sclerosis
n=5 Participants
Participants had two brain positron emission tomography (PET) scan visits. In one visit, participants had a baseline \[11C\]PS13 scan followed by a second \[11C\]PS13 scan after blockade with ketoprofen 75 mg orally. In another visit, participants had baseline \[11C\]MC1 scan followed by a second scan with \[11C\]MC1 after blockade by a dose of celecoxib 600 mg orally. Participants receive injection of up to 20 millicurie (mCi) of \[11C\]PS13 or \[11C\]MC1 during each scan.
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|---|---|
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Standard Uptake Value Ratio (SUVR) of Lesions With Injection of [11C]PS13 After Blockade With Ketoprofen
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NA SUV Ratio (SUVR)
Standard Deviation NA
Insufficient imaging signal above the lower limit of quantitation (LLOQ)
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PRIMARY outcome
Timeframe: 60-90 minutes after the start of PET scanPopulation: The analyses included only subjects who completed the study.
Calculation of standard uptake value (SUV) by averaging the SUV of all lesion voxels or tissue contralateral to lesion voxels in the PET image with injection of \[11C\]MC1 after blockade with celecoxib. Calculation of SUVR by averaging the SUV ratio between lesion or tissue contralateral to lesion voxels and the cerebellum from 60-90 minutes after the start of the PET scan.
Outcome measures
| Measure |
Participants With Multiple Sclerosis
n=5 Participants
Participants had two brain positron emission tomography (PET) scan visits. In one visit, participants had a baseline \[11C\]PS13 scan followed by a second \[11C\]PS13 scan after blockade with ketoprofen 75 mg orally. In another visit, participants had baseline \[11C\]MC1 scan followed by a second scan with \[11C\]MC1 after blockade by a dose of celecoxib 600 mg orally. Participants receive injection of up to 20 millicurie (mCi) of \[11C\]PS13 or \[11C\]MC1 during each scan.
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|---|---|
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Standard Uptake Value Ratio (SUVR) of Lesions With Injection of [11C]MC1 After Blockade With Celecoxib
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NA SUV Ratio (SUVR)
Standard Deviation NA
Insufficient imaging signal above the lower limit of quantitation (LLOQ)
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SECONDARY outcome
Timeframe: 60-90 minutes after the start of PET scanPopulation: The analyses included only subjects who completed the study.
Chronic active lesion is defined as the white matter lesion with paramagnetic outer rim in quantitative susceptibility maps (QSM). Standard uptake value (SUV) was measured by averaging the SUV of chronic active lesion voxels or contralateral normal appearing brain tissues in the \[11C\]PS13 PET image. The SUVR was calculated by averaging the SUV ratio between chronic active lesion or tissue contralateral to lesion voxels and the caudate from 60-90 minutes after the start of the PET scan.
Outcome measures
| Measure |
Participants With Multiple Sclerosis
n=5 Participants
Participants had two brain positron emission tomography (PET) scan visits. In one visit, participants had a baseline \[11C\]PS13 scan followed by a second \[11C\]PS13 scan after blockade with ketoprofen 75 mg orally. In another visit, participants had baseline \[11C\]MC1 scan followed by a second scan with \[11C\]MC1 after blockade by a dose of celecoxib 600 mg orally. Participants receive injection of up to 20 millicurie (mCi) of \[11C\]PS13 or \[11C\]MC1 during each scan.
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|---|---|
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Standard Uptake Value Ratio (SUVR) of Chronic Active Lesions With Injection of [11C]PS13
Chronic active lesion
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1.424 SUV Ratio (SUVR)
Standard Deviation 0.033
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Standard Uptake Value Ratio (SUVR) of Chronic Active Lesions With Injection of [11C]PS13
Contralateral normal appearing brain tissues
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1.455 SUV Ratio (SUVR)
Standard Deviation 0.196
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SECONDARY outcome
Timeframe: 60-90 minutes after the start of PET scanPopulation: The analyses included only subjects who completed the study.
Chronic active lesion is defined as the white matter lesion with paramagnetic outer rim in quantitative susceptibility maps (QSM). Standard uptake value (SUV) was measured by averaging the SUV of chronic active lesion voxels or contralateral normal appearing brain tissues in the \[11C\]MC1 PET image. The SUVR was calculated by averaging the SUV ratio between chronic active lesion or tissue contralateral to lesion voxels and the cerebellum from 60-90 minutes after the start of the PET scan.
Outcome measures
| Measure |
Participants With Multiple Sclerosis
n=5 Participants
Participants had two brain positron emission tomography (PET) scan visits. In one visit, participants had a baseline \[11C\]PS13 scan followed by a second \[11C\]PS13 scan after blockade with ketoprofen 75 mg orally. In another visit, participants had baseline \[11C\]MC1 scan followed by a second scan with \[11C\]MC1 after blockade by a dose of celecoxib 600 mg orally. Participants receive injection of up to 20 millicurie (mCi) of \[11C\]PS13 or \[11C\]MC1 during each scan.
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|---|---|
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Standard Uptake Value Ratio (SUVR) of Chronic Active Lesions With Injection of [11C]MC1
Chronic active lesion
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1.562 SUV Ratio (SUVR)
Standard Deviation 0.080
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Standard Uptake Value Ratio (SUVR) of Chronic Active Lesions With Injection of [11C]MC1
Contralateral normal appearing brain tissues
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1.724 SUV Ratio (SUVR)
Standard Deviation 0.143
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Adverse Events
Participants With Multiple Sclerosis
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Robert Innis
National Institute of Mental Health (NIMH)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place