Trial Outcomes & Findings for TSPO PET as a Measure of Post-stroke Brain Inflammation: a Natural History Cohort (NCT NCT03662750)

NCT ID: NCT03662750

Last Updated: 2021-06-30

Results Overview

PET-derived measures of TSPO radiotracer uptake in the infarct and peri-infarct areas at day 90 after a stroke (compared with Day 15)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 3 participants
• Primary outcome timeframe: 90 days
• Results posted on: 2021-06-30

Participant Flow

Participant milestones

Measure	Acute Stroke Cohort Participants with recent stroke
Overall Study STARTED	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Acute Stroke Cohort Participants with recent stroke
Overall Study Withdrawal by Subject	1

Baseline Characteristics

TSPO PET as a Measure of Post-stroke Brain Inflammation: a Natural History Cohort

Baseline characteristics by cohort

Measure	Acute Stroke Cohort n=3 Participants Participants with recent stroke
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United Kingdom	3 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days

PET-derived measures of TSPO radiotracer uptake in the infarct and peri-infarct areas at day 90 after a stroke (compared with Day 15)

Outcome measures

Measure	Acute Stroke Cohort n=3 Participants Participants with recent stroke
Changes in TSPO Radiotracer Uptake Infarct Area	1.54 g/mL Standard Deviation 0.39

PRIMARY outcome

Timeframe: 90 days

PET-derived measures of TSPO radiotracer uptake in ROIs distant from the infarct area (e.g. thalamus, hippocampi, amygdalae and midbrain) at day 90 after a stroke (compared with Day 15)

Outcome measures

Measure	Acute Stroke Cohort n=3 Participants Participants with recent stroke
Changes in TSPO Radiotracer Uptake Distant Area	0.89 g/mL Standard Deviation 0.04

Adverse Events

Acute Stroke Cohort

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

Prof Roland Veltkamp

Imperial College London

Phone: 020 3311 7296

Email: r.veltkamp@imperial.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place